Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: 3m scotchcast wet or dry cast padding
medical device manufacturer, 3m, has issued a medical device safety alert concerning certain lots of scotchcast wet or dry cast padding. the affected catalogue numbers and lot numbers are provided in the following table:-
catalogue numbers
lot numbers
wdp2
792920, 793090, 793640 & 796078
wdp3
792921, 793098, 793638, 796077 & 798487
wdp4
792922, 793116, 793637, 796079, & 798488
wdp6
792923, 793636, 798489, 799235 & 799236
the manufacturer is conducting a voluntary product recall of selected lots of 3m scotchcast wet or dry cast padding following a determination that the cast padding material does not consistently repel water. lack of repellency may result in prolonged cast dry times after exposure to wet conditions. the manufacturer become aware of this issue through health care provider feedback and confirmed it by internal testing. there is a potential of skin maceration under a cast exhibiting inconsistent repellency characteristics. there have been no reports of patient injury associated this material to date.
the manufacturer is advising all affected users that currently at the end user setting the captioned cast padding may be used under dry conditions only until replacement product is available.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 07 august 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: 3m universal electrosurgical pads
boston scientific has issued a medical device safety alert concerning 3m universal electrosurgical pads [sku: sgp-082-100, sgp-080-40; lot number: 2019-02dt, 2019-03du, 2019-02db; expiration date range: 1 feb 2019 to 1 mar 2019], manufactured by 3m.
this recall follows confirmation of a single user report of an unintended material (process liner) in the product. the presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site.
this removal affects only the lots listed in this notification. further distribution or use of any remaining product affected by this action should cease immediately.
according to the local supplier (boston scientific), the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 20 march 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: 3m espe imprint ii regular body vps impression material refill
medical device manufacturer, 3m espe dental products, has issued a medical device safety alert concerning its imprint ii regular body vps impression material refill 4-pack [catalogue number: 9379; lot number: n510884 and n510889].
the manufacturer is conducting a voluntary recall of the above affected products. the reason for the recall of this product is that the moisture displacement feature is greatly reduced, which may impact the quality of a dental impression.
the manufacturer will arrange for return and replacement of affected products.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 04 december 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott diabetes care freestyle insulinx blood glucose monitoring system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning freestyle insulinx blood glucose monitoring system, manufactured by abbott.
abbott has determined that at extremely high blood glucose levels of 56.8 mmol/l and above, the freestyle insulinx meter will display and store in memory an incorrect test result that is 56.8 mmol/l below the measured result. for example, a blood glucose value of 59.1 mmol/l will be displayed and stored as a value of 2.3 mmol/l (59.1 mmol/l–56.8 mmol/l = 2.3 mmol/l).
if the freestyle insulinx meter displays an inaccurate low result, there may be a delay in identification and treatment of severe hyperglycemia, or incorrect treatment may be given.
product recall and replacement is on-going from distributors and health care providers. the affected patients are advised to update the software on the affected meters immediately, or they can contact their local abbott diabetes care customer service for assistance.
according to the local supplier, abbott diabetes care, the affected product has not been distributed in hong kong.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con261768
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 april 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott vascular absorb bioresorbable vascular scaffold (bvs) and absorb gt1 bvs systems
medical device manufacturer, abbott, has issued a medical device safety alert concerning absorb bioresorbable vascular scaffold (bvs) and absorb gt1 bvs systems.
the manufacturer has recently published the results of absorb iii, a prospective randomized controlled clinical trial that compared the safety and effectiveness of the affected products to their metallic drug-eluting stent, xience. learning from an analysis of the absorb iii data and other published data have identified an impact on clinical outcomes following changes to procedural techniques. implementation of the techniques is expected to facilitate optimal clinical outcome and reduced the possibility of thrombosis.
according to the manufacturer, there is no need to return the affect products and patients who have had successfully implanted of the scaffolds are not affected by this action.
the manufacturer is issuing field safety notice to inform the customers about the key changes and will update the instructions for use.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 7 december 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect stat high sensitive troponin-i assay
medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect stat high sensitive troponin-i assay.
the manufacturer is informing affected users of a product recall and reduced expiration dating for select architect stat high sensitive troponin-i reagent lots. predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following the field action that occurred in january (fa21jan2016). as a result, the manufacturer has identified a potential for increased calibration failures prior to the expiration date.
according to the manufacturer, there is a potential for delay in results due to calibration errors and failure to calibrate. nonetheless, there is no impact to generated patient results.
manufacturer will continue to monitor performance of all on-market lots. until root cause is determined and corrective actions are implemented, new reagent lots will have a proactively shortened expiration date of 4 months from date of manufacture. the expiration date will require adjustments to the laboratory inventory and order management practices.
affected users are instructed either:
to destroy any remaining inventory of affected lots once an alternate reagent lot is available, or
to adjust the expiration date of the affected lots
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 3 may 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect active-b12 reagent kit
medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect active-b12 reagent kit. the affected devices are identified as follows:-
list number: (i) 3p24-25, (ii) 3p24-35
lot number: (i)10533up00, (ii)10534up00
udi number:
(i) [(01) 00380740006365, (17) 170529, (10) 10533up00, (240) 3p2425]
(ii) [(01) 00380740006372, (17) 170529, (10) 10534up00, (240) 3p2435]
expiration date: 29 may 2017
the manufacturer has identified a lot specific stability issue with both reagent lots 10533up00 and 10534up00. as the reagent ages, relative light unit (rlu) values for the calibration curve will decrease causing patient results calculated from this depressed curve to over-recover, potentially resulting in falsely elevated patient results. controls may not reflect reagent instability as recalibration may result in control values within acceptable ranges.
there is a potential for falsely elevated active-b12 results to be generated when using architect active-b12 reagent lots 10533up00 and 10534up00. internal studies have determined the worst case magnitude of elevation to be up to 30% for active-b12 concentrations close to 20 pmol/l and up to 20% for concentrations close to 30 pmol/l.
affected users are instructed to discontinue use and immediately destroy any remaining inventory of architect active-b12 reagent lots 10533up00 and 10534up00 and order replacement material. they should also review the information with their medical director to determine if a review of results previously generated with reagent lots 10533up00 and 10534up00 is required.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 december 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect shbg reagents
medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect shbg reagents. [list numbers (lot numbers): 8k26-20 (01916e000, 00316f000, 01816g000, 00916i000, 07316i000, 00916l000] and 8k26‐25 (01816e000, 00216f000, 01716g000, 00816i000, 07216i000) ].
the manufacturer has identified that architect shbg results generated with the potassium edta specimen tube type may demonstrate a negative shift relative to results generated with serum. shbg dimer destabilization in edta could result in low shbg measurements by immunoassay.
there is a potential for falsely decreased architect shbg results to be generated when using the architect shbg assay with the potassium edta specimen tube type.
internal studies have determined use of the potassium edta specimen tube type may result in a decrease in shbg concentration values of greater than 20% when compared with serum collected in serum tubes. the shift was observed across the full analytical range of the assay.
as a result, an increase in free androgen index / free testosterone index calculations of up to 30% may also be observed when using potassium edta specimen tubes.
affected users are instructed to discontinue use of the potassium edta specimen tube type with the architect shbg assay according to their laboratory procedures. the issue should be reviewed with their medical director to determine if a review of results previously generated using the potassium edta specimen tube type is necessary.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 april 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: heartmate 3 left ventricular assist system
medical device manufacturer, abbott, has issued a medical device safety alert concerning its heartmate 3 (hm3) left ventricular assist system [catalog number: 106524int – hm3 lvas kit].
the manufacturer has received reports of outflow graft twist occlusions in the heartmate 3 left ventricular assist system. as a result, patients whose devices experience these outflow graft occlusions will experience a persistent low flow alarm.
according to the manufacturer, there are 32 total reports associated with outflow graft twisting in the hm3 device, an occurrence of 0.72 percent based on 4,467 implants worldwide outflow graft twists can result in serious adverse events such as hemodynamic compromise, thrombus, and death. postoperative twisting and occlusion of the hm3 outflow graft may result in the need for surgical intervention following the original implant procedure.
the affected users are advised to take the following actions:
during implant, when attaching the outflow graft to the pump cover, a clicking sound will be heard as the screw ring is tightened. continue turning the screw ring clockwise until it comes to a complete stop and stops clicking for a firm hand tightened connection.
if a low flow alarm persists at any time following implant, and other potential causes such as hypertension, low preload, right-heart failure and inflow occlusion have been considered for cause, a computed tomography angiography should be taken to identify the possibility of an outflow graft twist occlusion.
in the event surgical repair of the outflow graft is needed due to a twist occlusion, the outflow graft bend relief should be reattached in its original state or repaired to prevent further kinking or occlusion of the graft.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 12 april 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott alinity i processing module
medical device manufacturer, abbott, has issued a medical device safety alert concerning its alinity i processing module [list number: 03r65, serial numbers: ai01001 to ai01336].
the manufacturer has identified an issue with the alinity i bulk solution dispense pumps (part number a‐35001280‐01) resulting in pump failures. the issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution. the failure of the pump could result in unexpected instrument down time potentially causing a delay in generating results.
according to the manufacturer, the amount of the leakage does not impact the ability of the pump to accurately dispense bulk solutions, and the leakage is contained within the service‐only area of the instrument. therefore, the issue does not pose a risk of incorrect results nor a risk of physical exposure to the operator.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 21 sep 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott diabetes care freestyle libre flash glucose monitoring system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning freestyle libre flash glucose monitoring system, manufactured by abbott diabetes care.
according to the fsn, one of the safety features of the freestyle libre system is the software, which is designed to disable the sensor if it identifies a possible loss of sensor power. in rare cases this disabling feature may not function correctly, and there is the potential for power loss to occur which may not be properly identified by the system. in these instances, when a scan is completed the sensor may provide previously collected glucose values as if they are current results. if this occurs, the results produced from the scan and seen on the reader screen may be erroneous. however, the built-in blood glucose meter system is unaffected by this issue.
the above issue can be easily identified as the user would see the same glucose result on the screen each time they scanned during a period of power loss. they may also notice a gap in results on the 8-hour graph on the reader screen.
if any reading from a scan seems unexpected or does not seem to match the way users are feeling, users should use the meter and test strips to perform a blood glucose test to verify the results produced by a scan. if the problem continues, users should contact abbott diabetes care customer service. furthermore, the manufacturer has made a change to the software that has corrected this issue for all newly manufactured freestyle libre sensors.
for details, please refer to mhra website :
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con462307
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 14 october 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: freestyle optium neo blood glucose and ketone monitoring system
it has come to our attention that medical device manufacturer, abbott diabetes care, has issued a field safety notice concerning a glucose and ketone monitoring system - freestyle optium neo blood glucose and ketone monitoring system.
the manufacturer has become aware that a basal insulin titration feature of the affected product, which provides users with a long acting insulin dose suggestion, may in error recommend “0” units of insulin to be taken.
this issue is encountered when the feature has been activated by healthcare professional (hcp), while the patient is in glycaemic control and their average fasting blood glucose level is within the target range that the hcp has set. the meter should suggest the basal dose that the patient took the prior day, but instead is incorrectly recommending “0” units. therefore, the manufacturer advises the users not to use this affected feature, if activated.
according to the manufacturer, the issue would not pose a significant risk to user’s health or safety. the users may continue to test their blood glucose and/or ketones as this issue does not impact blood glucose and/or ketone results received from the meter. as a permanent solution, the manufacturer will update the firmware of the product.
according to the local supplier, the affected product is distributed in hong kong; nonetheless, only those units with activated basal insulin titration feature would be involved.
if you are in possession of the affected products and currently using the long acting suggestion, please contact your supplier and hcp for necessary actions.
posted on 24 august 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott laboratories architect intact pth assay
medical device manufacturer, abbott laboratories, has issued a field safety notice concerning certain lots of architect intact pth assay with list numbers: reagents (8k25-20, 8k25-25, 8k25-27), calibrators (8k25-01) and controls (8k25-10).
the manufacturer has confirmed that a performance shift in the architect intact pth assay has the potential to generate falsely elevated results on patient samples. results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. the issue may also impact established architect intact pth reference ranges. abbott architect intact pth controls do not detect the shift. all current reagent, calibrator, and control inventory is impacted. falsely elevated patient results are generated when using the architect intact pth assay.
the manufacturer advises users of the followings:
to discontinue use of, and destroy, any remaining inventory of affected products;
to continue intact pth testing at the laboratory, users should identify an alternate method for testing patient samples; and
the field safety notice should be reviewed with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary.
for non-enterobacteriaceae (quality control purpose), the mic shift over the time can be greater than +1 dilution when compared to the mics initially obtained at the time of the release. for enterobacteriaceae, the over-estimation of mic can change the category result of isolates having mic equal or close to the breakpoint. according to the manufacturer, this performance issue leading to this over-estimation of mic can be detected using the quality control as recommended in the etest package insert.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 14 february 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott alere nt-probnp for architect controls
medical device manufacturer, abbott laboratories, has issued a medical device safety alert concerning its alere nt-probnp for architect controls. the affected devices are identified as follow:
list number: 2r10-10;
lot number: a) 902917627; b) 902918346
expiration date: a) 19 december 2018; b) 16 february 2019
udi number:
a) (01)05055845400404(17)181219(10)902917627;
b) (01)05055845400404(17)190216(10)902918346
abbot laboratories becomes aware that the manufacturer of the alere nt-probnp for architect controls, axis-shield, has identified a stability issue that may lead to quality control values falling outside of expected ranges prior to assigned expiry date.
according to the manufacturer, a potential delay may exist in the reporting of patient results due to quality control values falling outside of expected ranges. internal testing on patient samples showed no atypical bias for the impacted lots, therefore if quality controls are in range, patient results are not impacted.
if affected users have an alternate control lot available in inventory, they should immediately discontinue use of the affected control lot(s) and switch to the alternate control lot. they should also destroy any remaining inventory of impacted material according to their laboratory procedures.
if the affected users do not have an alternate control lot available in inventory and the current lot continues to generate valid qc results, they should immediately order a replacement control lot. they may continue to use the affected control lot(s) while following their current laboratory qc procedures. once they receive the replacement control lot, they may destroy any remaining inventory of impacted material according to their laboratory procedures.
product replacement is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 4 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect lactic acid
medical device manufacturer, abbott laboratories limited, has issued a medical device safety alert concerning its architect lactic acid [list number: 9d89-21; lot number (expiration date): 31497un14 (17 oct 2016); 09353un15 (12 feb 2017); 45216un15 (12 may 2017); 14596un15 (30 jul 2017); 37055un15 (12 oct 2017); 14782un16 (21 apr 2018)].
the manufacturer has identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid reagent (ln 9d89-21).
according to the manufacturer, the levels of interference observed at nac concentrations of 80 mg/l (0.49 mmol/l) and 800 mg/l (4.9 mmol/l) have been outlined in the field safety notice (fsn). patients undergoing treatment with nac may have falsely depressed lactic acid results.
the affected users are advised to take the following actions:
review the fsn with their medical director
taking the fsn into consideration, they may continue to use architect lactic acid reagent (ln 9d89-21)
retain the fsn for their laboratory records
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 13 october 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott laboratories m2000sp instrument
medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning m2000sp instrument, with affected list number 09k14. all assays run on the m2000sp instrument that require manual entry of calibrator and control expiration dates, lot numbers, and calibrator and control concentration values were affected.
according to the manufacturer, there was an issue on the m2000sp instrument software when information is entered incorrectly during the creation of a sample extraction test order. an issue may occur only when the correction is made to manually entered calibrator or control information after the operator have progressed beyond the "sample extraction: sample scan" screen and the operator do not re-scan the sample tubes and racks after data correction on the "sample extraction: assay detail" screen. an issue with the m2000sp instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the sample extraction assay details screen, the changes are not saved. this software issue will occur if some specific steps are followed.
furthermore, the manufacturer advises users that when entering calibrator or control information on the sample extraction: assay details screen, verify that the information is correct prior to proceeding to tile next screen. if identifying that the entered information is incorrect, users can correct the information by following options or steps suggested by the manufacturer. the manufacturer will deploy a new corrective software upgrade by the end of first quarter 2013.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 17 december 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott laboratories architect anti- hbc ii reagent
medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning architect anti- hbc ii reagent kit, with the following details:
list number: 8l44-25; 8l44-30; 8l44-35;
lot number: 42072li00; 42072li01; 42253li00; 42253li01; 42255li00; 42255li01; 42256li00
according to the manufacturer, the affected product shows lower calibrator, control and sample relative light unit (rlu) values, potentially leading to reduced specificity and increased false reactive results. internal testing showed specificity dropped to 99.2% which is below the package insert claim of 99.5% on a blood donor population. there is the potential for false reactive patient results but assay sensitivity is not impacted.
the manufacturer advises users not to use the affected lots and destroy any remaining inventory of these lots according to their laboratory procedures.
according to the local supplier, the affected product is distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 march 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott laboratories alkaline wash
medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning alkaline wash, with the following details:
list number: 9d31-20
lot number: 49059un14
expiration date: 4 march 2016
the manufacturer is recalling the affected product due to leaking and/or material received with loose bottle caps that may have leaked during shipment
the manufacturer has given the following advice to users: -
while wearing the appropriate personal protective equipment (ppe), visually inspect the inventory.
if users observe any signs of leakage or loose caps, they should discontinue use and dispose of any remaining inventory of those kits in accordance with their institution’s policies and procedures.
if users do not observe any signs of leakage or loose caps, they may continue to use the product following the precautions per the architect system operations manual and the safety data sheet.
according to the local supplier, the affected product is distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 may 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect estradiol reagent
medical device manufacturer, abbott laboratories ltd, has issued a medical device safety alert concerning its architect estradiol reagent. [list number: 7k72; lot numbers: all].
the manufacturer has confirmed that the drug fulvestrant (faslodex) may interfere with the architect estradiol assay (ln 7k72) leading to falsely elevated estradiol results.
the potential risk to health applies only to patients being treated with the drug fulvestrant which may lead to increased estradiol results.
in worst case scenarios, falsely elevated estradiol results may lead to incorrect menopausal state assessment and inappropriate therapy.
the manufacturer advises users that patients undergoing fulvestrant therapy should not be tested with the architect estradiol assay.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 april 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect ict module
medical device manufacturer, abbott laboratory, has issued a medical device safety alert concerning its architect ict module. the affected devices are identified as follow:
list number: 09d28-03;
lot number: 180326;
expiration date: 26 december 2018;
udi: (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399.
the manufacturer has received customer complaints regarding higher than expected serum or plasma chloride results when using the affected products. based on an analysis of quality control (qc) data from existing customers, the results generated using this lot number may be up to 6.2% higher than expected. the customer qc data do not indicate an issue with urine chloride results.
according to the manufacturer, the issue only impacts the chloride electrode element of the ict module, potassium and sodium results are not impacted. there is the potential to generate falsely elevated serum or plasma chloride results when using the affected products. there is also the potential to delay the reporting of chloride ict results due to the time required for the user to attempt troubleshooting of the issue with falsely elevated serum chloride qc results.
the affected users are advised to immediately discontinue the use of the affected products. they should destroy any remaining inventory of the impacted lot number according to their laboratory procedures. they also should discuss with their medical director and follow their laboratory protocol regarding the need for reviewing previously reported patient results.
product replacement is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 4 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific lotus valve system
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning lotus valve system [material number: h749ltv230. batch numbers: 17520706, 17520708, 17520709, 17520717, 17520781, 17520785, 17520787].
the box carton labels for the above seven affected lots display an incorrect expiration date which is one month later than the actual expiration date.
product recall is ongoing.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 15 april 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific extractor pro rx 9-12mm above retrieval balloon catheter
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning extractor pro rx 9-12mm above retrieval balloon catheter [material number: m00547000. lot number: 17673858. expiration date: 28 february 2017].
the affected devices are identified as follow:-
the manufacturer has become aware that one lot of extractor pro rx may contain an incorrect sized syringe, which is larger than the size identified on the label.
product recall is ongoing.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 4 may 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific repliform tissue regeneration matrix
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning repliform tissue regeneration matrix [material number (upn): m0068202410; lot: ah102318010, ah102317009, ah102318026; expiration date: 31 january 2017].
boston scientific, as the distributor of lifecell corporation’s repliform tissue regeneration matrix, is implementing a recall on behalf of lifecell corporation. lifecell has informed boston scientific corporation that the incorrect ink was used in the manufacture of the printed backing component of the lots identified below. this could potentially lead to the transfer of ink from the printed backing component to the repliform tissue regeneration matrix and subsequent patient implantation.
per lifecell’s toxicological analysis and health assessment, exposure to the chemicals found in the ink at the levels used is unlikely to pose a safety concern. if affected repliform matrix was implanted, there is a potential for a local transient inflammatory response. there are no identified long term health consequences.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 14 may 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific reliance 4-front
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning reliance 4-front. the affected devices are identified as follows:-
model numbers: 1) 0682; 2) 0692
serial numbers:
1) 121478, 121502, 121485, 121503, 121488, 121504, 121489, 121505, 121490, 121506, 121491, 121507, 121494, 121509, 121495, 121510, 121497, 121511, 121501, 121514;
2) 121454, 121466, 121481, 121516, 121527, 121455, 121467, 121482, 121517, 121528, 121456, 121468, 121483, 121519, 121530, 121458, 121469, 121484, 121520, 121531, 121459, 121470, 121487, 121521, 121532, 121460, 121472, 121492, 121522, 121533, 121461, 121473, 121493, 121523, 121534, 121462, 121475, 121496, 121524, 121538, 121463, 121476, 121508, 121525, 121540, 121464, 121477, 121515, 121526, 121541, 121465, 121479
according to the manufacturer, one lead of a subset of seventy-two boston scientific reliance 4-fronttm single coil defibrillation leads distributed in europe and japan exhibited intermittent high pacing impedance and oversensing at implant.
laboratory analysis determined that the terminal ring for the distal shock electrode was not fully connected to the conductor cable. further investigation determined that manufacturing equipment used to attach the terminal ring to the conductor cable was slightly offset from the intended position for a short period of time. the seventy-two leads were manufactured during this offset period, and may have a terminal ring that was not fully connected to the conductor cable.
if the terminal ring is not securely connected to the conductor cable, potential clinical symptoms may include high or intermittently high pacing or shock lead impedance, noisy electrograms (egms) (particularly during pocket manipulation), or sensing anomalies that could affect either pacing pulses or shocks. a terminal ring that is not fully connected to the conductor cable could cause clinical symptoms during the replacement procedure.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 may 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific autogen and dynagen
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its implantable defibrillators, autogen and dynagen. [model: i) model g150 dynagen crt-d; ii) model d020 dynagen mini icd; iii) model g172 autogen crt-d; iv) model d044 autogen mini icd. serial numbers: i) sn100195, sn100153; ii) sn100079, sn100121; iii) sn100476, sn100550; iv) sn100197, sn100292].
the manufacturer forwarded eight devices to avalon medical international s.A. for product registration purposed in venezuela. these devices were labelled “not for human use”. the manufacturer learned both through a venezuelan doctor and the sub-distributor in venezuela that four of the devices were implanted in patients in venezuela. the manufacturer later determined that the implanted devices are in fact suitable for use in humans. the manufacturer requires all affected users and distributors to establish mechanisms to prevent the above-mentioned situation from happening again.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 03 june 2015.