Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
All lots may exhibit a higher than expected rate of error codes
for plasma samples, all lots have the potential to exhibit false “not detected" results for hiv
samples less than 120 copies/ml when using 0.6 ml assay application.
for dried blood spot (dbs) samples when using a 1-spot protocol associated with the
realtime hiv-1 package insert 51-608282, all lots are performing in accordance with the
detection rate within the realtime hiv-1 package insert for dbs sample types.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Abbott vascular is voluntarily issuing this field safety notice for the mitraclip clip delivery system,
product number msk02st. the mitraclip system contains the clip delivery system, product number
cds02st, and the steerable guide catheter, product number sgc01st.
abbott vascular has recently received nine reports of cases on clip delivery system devices that contain
the one‐way actuator knob (lot number 50714u1 and greater) where a user attempted implanting a
mitraclip, but the clip could not be detached from the delivery system due to a mandrel fracture. these
cases resulted in surgical interventions and, in one case, the patient expired post‐operatively due to
severe comorbidities. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Abbott vascular has initiated a voluntary field action regarding specific lots of the starclose se
vascular closure system. our records indicate that affected lots have been shipped to your
account.
product from the identified lots may exhibit difficulty or failure to deploy the starclose se clip.
potential risks associated with this event include prolonged procedure times, use of another
device or manual compression to achieve hemostasis. there have been no long term or
irreversible patient effects reported.
this action does not affect patients having successfully undergone cardiac or endovascular
procedures using the starclose se vascular closure system. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Abbott vascular has initiated a voluntary field action regarding specific lots of the nc trek rx
coronary dilatation catheter, nc traveler rx coronary dilatation catheter, and nc tenku rx
ptca balloon catheter. our records indicate that affected lots have been shipped to your account.
product from the identified lots may exhibit difficulty in removing the protective balloon sheath which
can result in issues with inflating or deflating the balloon. the worldwide frequency of tight sheath
removal, inflation and deflation reported events is 0.12%. potential risks associated with balloon
inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and
myocardial infarction. in one reported case, failure to deflate the balloon necessitated surgery,
leading to multiple post-operative complications and death. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Abbott vascular is seeking, together with european regulatory agencies, (competent and notified bodies) and the professional medical community, additional factual evidence for the absorb and absorb gt1 biodegradable vascular support systems (bvs) in the european market. we will achieve this through registries in collaboration with the community of our key physicians. the registers will cover the implantation of all sizes of absorb and absorb gt1 biodegradable vascular system (bvs) systems in the european market.
from may 31, 2017, the device will only be available for use within the clinical registry at selected hospitals / institutions, which will play a key role in monitoring this technology until summer 2018 when we review the situation.
restricting use to these registers will allow the systematic collection of data to answer questions posed at a recent congress, three-year clinical data, and an analysis of the use of absorb ii on the incidence of abdominal thrombosis and the optimal duration of dapt implantation. this will help us show the impact on clinical outcomes following changes in implant technology. we have taken these important restrictive measures in light of recent questions about the increased incidence of serious adverse cardiac events,
notably myocardial infarction and abdominal thrombosis, while we await further data to determine if improved implantation techniques will mitigate this increased incidence of events and evaluate the longer-term benefits associated with using absorb.
as we continue to use bvs absorb and absorb gt1 systems over the past few years, we have gathered clinical evidence to support implant techniques that provide optimal clinical outcomes. key knowledge from this experience includes the importance of an appropriate implantation technique that you can
express with the abbreviation psp (prepare the vessel, size appropriately, post-dilate - prepare the vessel, select the appropriate size, dilate according to the procedure). recent analysis data, such as those conducted in the european ghost-eu1 registry, four cities2 and in studies provided by
sponsored by abbott3, emphasize the importance of implantation techniques in optimizing short- and long-term outcomes. the frequency of events recently reported from the use of absorb systems in actual studies in europe, such as that conducted by dr. tanaka4 et al. brugaletta1, is consistent with the incidence of events with a number of currently approved state-of-the-art drug-excreting metal stents (des).
1 psp analysis on ghost eu - impact of technique on clinical outcomes - s. brugaletta - tct 2016
2 gori, t. 4 cities registry, europcr 2015
3 psp analysis - impact of procedural technique on long term adverse outcomes in the absorb trials - a first look - s.
ellis - tct 2016
4 tanaka a, latib a, kawamoto h, jabbour rj, sato k, miyazaaki t, naganuma t, magieri a, pagnesi m, montalto c, cheiffo
a, carlino m, montorfano m, colombo a. clinical outcomes of a real world cohort following bioresorbable vascular scaffold
implantation utilizing an optimized implantation strategy. eurointervention 2016: jaa-004 2016, doi10422 / eij-d-16-00247 5 psp
analysis - impact of procedural technique on long term adverse outcomes in the absorb trials - a first look - s. ellis -
tct 2016
6 gori, t. 4 cities registry, europcr 2015
7 everolimus-eluting bioresorbable vascular scaffolds in patients with coronary artery disease: the absorb iii trial - g. stone
- tct 2015
8 absorb iv trial - g. stone - jim 2017
in addition, treatment of veins with a reference diameter (rvd) greater than 2.50 mm (greater than 2.25 mm when measured by qca) has been shown to reduce the incidence of st events to a level comparable to xience.5. 6.7 finally, data from the absorb iv8 trial, the most recent randomized controlled trial in the absorb trial group, showed preliminary st events (in the blinded analysis of the data collected) that were less than the analysis of the collected data in the 30 days absorb iii trial. and interim data after 1 year. these data also confirm the importance of avoiding very small vessels and dilatation following the procedure as factors that may contribute to the reduction of st frequency.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Stryker orthopaedics has received four (4) reports of disassociated components of the scorpio patella
assembly instrument. an investigation revealed that the press-fit specifications between the pin(s) and
either one or both clamping subcomponents were not met. no adverse patient consequences were
reported. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
This action is being initiated as a result of alere’s post market surveillance activity. specifically, negative results were obtained from a single sample in the eqa ring trial in europe. this sample was taken from a 40 year old man with a 7 day history of fever, rash and fatigue and contained p24 antigen of a virus of subtype c at a concentration of 250 pg / ml (viral load of 2,500,000 copies / ml), corresponding to 50 iu / ml (who standard). a recent publication of a survey conducted in swaziland also suggested that the antigen component of the alere determine hiv-1/2 ag/ab combo test in a high-prevalence, high-incidence setting was unable to detect acute infection in this subtype c population (yen t. duong et al., j. clin. microbiol. 2014, 52(10):3743-3748). .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Patients may be exposed to unnecessary treatment if the instructions for use and other requirements for testing the algorithms are not followed closely, and if clinical measures are taken on the original p24 antigen-positive sample.
with this safety notice, we want to inform users that tests from the series below are more likely to detect the presence of p24 antigen, and to remind them of the recommendation in the package leaflet to confirm all initially positive results (indicating the presence of p24 antibodies and / or antigen) by the second method.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Due to weakly visible test lines in the said batches, it came to an increased amount of false-negative results.
although the potential risk is considered to be minor with a test considered to be a pre diagnostic test, the
product is being recalled from the european market by the gabmed gmbh as a precautionary measure to
prevent false negative results. as the test is used as an aid in diagnosis, there is residual risk that additional
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Of the 398,740 devices sold worldwide, 841 were returned for analysis due to premature discharge
battery, the formation of lithium "clusters" in the battery. at forty-six (46), clusters were seen which
bridged the cathode and anode and caused a short circuit. lithium clustering is a well-known phenomenon in this type of battery.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
The result of a review of the currently available stryker rhead radial head and uni-elbow data showed that there were no conclusive results further supporting the use of the device. because of this, we decided to withdraw the product from markets worldwide.
healthcare professionals working with patients using the stryker rhead radial head / uni-elbow prosthetic system should continue to monitor such patients in accordance with routine care standards, as no additional harm was detected.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Stryker neurovascular has noticed that some target nano products lack adequate tensile strength. joints within the coil providing tensile strength may have been damaged during production, which may lead to increased coil stretching.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Stryker orthopaedics has received reports of the thread length protruding past the
dome of the acetabular trial or implant. upon investigation, it was determined that the
press fit between the threaded stud and the handle shaft assembly for the trident
universal impactor/positioner (p/n: 2101-0200) may lead to the gradual protrusion of
the threaded stud over time.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Stryker became aware during laboratory testing that there is a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognized, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch?.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Thoratec is issuing this urgent field safety notice to remind all hospitals to carefully monitor the expiration date of the 11v lithium-ion backup battery (“backup battery”) in the heartmate ii lvas system controller. failure to do so can result in preventable backup battery advisory alarms and unwarranted system controller exchanges by patients. thoratec has received reports of two patient deaths and one serious injury associated with patients attempting to exchange system controllers in response to these alarms. thoratec’s investigations of the reports have not revealed any failure of the devices to meet specifications or deficiencies in quality control procedures that would have caused the backup battery advisory alarms.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
As part of the follow-up to our last message in september 2015, we remind you that thoratec corporation, part of the abbott laboratories group, is updating its alerts, upgrading software, and adding heartmate ii® system controller alignment tags as part of an ongoing effort to be able to emergency patients successfully replaced their pocket controller.
in 2014, several improvements were made to training and education following the voluntary introduction of revisions to the patient controller replacement process. as a consequence, we found that the rate of adverse events in system controller replacements decreased by 80%. as many as 90% of the system controller controls that were previously replaced at home are now replaced in the hospital, according to the operating instructions. nevertheless, patients still experience a very low rate of side effects (including severe injury or death) in 0.1% of the total, which is due to unnecessary replacement of the patient's controllers. it is best if system controller replacements are performed by health care personnel in a controlled environment.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Acutronic received a customer complaint. ln conjunction with the enabling of the sp02 option, there are rare cases where the freezing of spi interface can iead to a situation where the gui freezes and ventilation stops. the ventilatorwill alarm with both analarm so und and a blinking red alarm led. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Our records indicate that 1 customer have received this product in Slovenia.
Cause
Baxter healthcare corporation is updating the homechoice patient at-home guide addendum to include a discussion of the expected operating sounds associated with all homechoice and homechoice pro devices. the new labeling will address the following: the homechoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the homechoice cycler. there will be sounds like humming, swishing, clicking, and venting (air being released) that are normal for the operation of the cycler. in certain portions of the therapy, the sound level is expected to increase which is also part of normal operation. if there is a significant change in the sound level or a new, previously unheard sound when using the homechoice cycler, please contact your doctor and/or nurse or baxter technical services. no auditory damage is expected from the level of noise generated by the homechoice, even in case of “noisy device”. the expected outcome for a noise issue is the notification to the clinician / technical service. if the noise is identified as undesirable, the homechoice will be swapped. in this case, an interruption in the therapy is unlikely as the unit continues to operate and remain capable of delivering therapy. for the patients who elect not to continue with therapy, a swap may result in a delay of therapy of less than 48 hours and mild overload and/or electrolyte imbalance may result. however, during homechoice training, patients are instructed to be able to perform manual therapy at home in case of device swap situation when the unit is not functional. in conclusion, while this issue may temporarily impact the patient’s quality of life (temporary discomfort), permanent injury is not expected. as worst case scenario, for the general population, missing therapies may result in mild fluid overloaded and/or electrolyte imbalance. this outcome is considered a minor severity or transient adverse health consequences. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
We have identified a quality deviation in the latest production lot of footrest vacuum
pumps. during germa quality check before delivery, the footrest vacuum pump works
normal and according to our test procedure. the quality deviation in latest production lot
may occur after some time of use, when the pump has been exposed to greater forces
making rigid evacuation. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Following further clinical evaluation by advanced medical solutions (ams), with effect from may
2015 the indications for use of the liquiband® f|x8"”i device (product) were extended from
”laparoscopic surgical repair of inguinal hernia, achieved through the fixation of polypropylene or
polypropylene / polyester combination hernia mesh to the abdominal wall” to "laparoscopic repair
of abdominal hernias, achieved through the fixation of prosthetic mesh to the abdominal wall and
the approximation of peritoneum” (extended claims). during a recent routine technical file audit by
our notified body (bsi), they confirmed that more data was required to support these extended
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
To prevent centrifuge failure, siemens healthcare diagnostics recommends that you follow the instructions in
the attached letter from the manufacturer of the hettich laboratory centrifuges and the maintenance instructions
hettich laboratory centrifuges.
we assure you that in order to achieve a long-term solution, we work closely with the laboratory manufacturer
centrifuge hettich.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
On july 13' 2015 three lot of ala®octa were recalled, the analysis of the cause of reported incidents
which were linked to the ala®octa is still ongoing. despite of comprehensive analysis of a variety of all
produced ala®octa lots‘ which so far confirm high purity and conform biocompatibility (no in vitro
cytotoxicity), alamedics recalls all ala®octa from all markets until the investigations are completed to
protect all patients.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
Swissmedic assessed that ala®purple did not comply with the requirements of eu directive 93/42 / eec. swissmedics presents an opinion on the non-compliance on the basis of an assessment of the biocompatibility evidence submitted during the registration process. documentation compiled by the manufacturer to determine the temperature range 5 ° c to 40 ° c for storage and transport the product is classified as defective and therefore not compatible.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
It has come to our attention that some boxes of laseredge 15 degree stab blade 6/box, sku#e7515 lot masd750 contain blisters of sku# e7596 lot masd750. please review carefully the notes outlined in this letter regarding your laseredge 15 degree stab blade 6/box, sku#e7515 lot masd750. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
Notes supplémentaires dans les données
Cause
It was found that a lower reading may be given for the glucose item when the blood glucose concentration
of a sample exceeds approximately 350mg/dl. more specifically, when the blood glucose concentrafion
exceeds the upper limit of the measurement range (450mg/dl), the message ”over”, indicating that the
reading is outside the measurement range, was not displayed and readings of approximately
300~400mgldl may be given.
in addition, when within the measurement range, for high glucose concentrations (approximately
350~450mgldl), there is a possibility that the reading may be around -20% of the known concentration.
.