Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Baxter healthcare corporation has identified potential leaks during regular clinical use of the ultrafilter u9000. the leaks are caused by cracks near the header cap due to the stress of repeated disinfection cycles over the lifetime of the product. the current instructions for use (ifu) state the ultrafilter has a maximum lifetime usage of 90 days, or 150 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. in order to reduce the patient risk associated with the occurrence of leaks, the ifu will be updated to reduce the maximum lifetime usage to 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles when the ultrafilter is used in conjunction with ak96 and ak98 v1 dialysis machines. other machines using these filters have a leak detector sensor that will trigger an alarm.
Action
Baxter is advising that operators may continue to use affected units with AK96 and AK98 v1 dialysis machines according to the new maximum lifetime usage criteria of 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles.
If Ultrafilters currently in use with AK96 and AK98 v1 machines have exceeded any of the new maximum lifetime usage criteria, it is recommended the filter be changed.
Baxter will reset the AK 96 & AK 98 v1 monitor counters to the reduced maximum usage during the next scheduled preventive maintenance.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
It has been identified that when a reagent vial with an unreadable barcode is loaded on a reagents rack on ih-1000 (software version 04.07.02) and a test is performed, despite the fact the first reagent is correctly pipetted, the instrument will pipette from the vial with unreadable barcode for all the remaining wells. the system will add serum and continue as normal without alarm.This error happens following a specific sequence of events:1. use ih-1000 in version 04.07.022. load a reagent in a reagent rack3. the barcode on the reagent vial is not readable4. perform a test requiring the reagent with the unreadable barcode 5. validate the results through ih-com.
Action
BioRad is advising customers to restore the previous version of software 04.04.08. Users may contact Bio-Rad Laboratories to arrange for replacement software.
BioRad is advising users to review previous results obtained since the installation of the affected software version. This can be done by checking the lot numbers in the daily journal in IH-Com. If the lot number does not appear do not use the test results and perform the test again.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Fisher & paykel healthcare has identified a firmware anomaly which prevents the fisher & paykel sleepstyle from recording clinical data, and may delay remote prescription changes if the device is continually powered for 20-50 days. this time frame may vary depending on the number and length of therapy sessions. the firmware anomaly does not prevent the ongoing delivery of currently prescribes setting and therapy does not affect any other functions of the device. only devices with v1.1.0 firmware are affected.To date, no complaints resulting in injury have been received relating to this issue.
Action
Fisher and Paykel will be contacting distributors, hospitals and retailers to arrange for hardware upgrade to be installed in affected units.
For devices currently used in a home setting, this action does not impact products with activated modem capabilities. For affected product without modems, have non-activated modems or modems out of service, continuous data recording can be ensured by reminding users to follow instructions in the SleepStyle Use and Care guide to unplug and clean the device every 7 days.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
It has been identified that there is a difficulty connecting the female luer to haemodialysis blood tubing lines, end caps and syringes which may result in blood or air leakage at the connection site. to date, there have been no reports of injury in australia as a result of this issue.
Action
TekMed is requesting customers immediately review their stock on hand for affected units and to discontinue their use and distribution. Affected product should be returned to TekMed who will issue a suitable account credit.
New unaffected product is currently being manufactured.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
This recall is being conducted due to the potential for loss of activity of the glucose analyte prior to the full stated shelf life (august 2018).Based on the results of internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results. this issue may result in the delay in diagnosis of diabetes. there have been no adverse events reported in conjunction with this product.
Action
Point of Care Diagnostics (PTS) is advising users to inspect stock and quarantine any remaing kits of the affected lots. Affected stock is to be destroyed. PTS will issue replacement product or a credit note.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Heartware, now a part of medtronic, has identified the potential for a transient interruption of the electrical connection between an hvad system power source (battery, ac adapter, or dc adapter) and the hvad controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones (“beeping”). this interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller’s power source socket, and typically lasts 1-2 seconds. unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or ac/dc connectivity at the time of the audible tone. a critical battery alarm may also be momentarily displayed due to this phenomenon.
Action
Medtronic is developing mitigations for current patients and future system enhancements have been identified and pending approval. Medtronic will inform users when these have been made available.
In the interim, Medtronic is providing the following recommendations for power source management of HVAD Systems:
- Reinforce the importance of always ensuring TWO power sources (AC or DC adapter plus a battery, OR two batteries) are connected at all times (except when changing a power source)
- Reinforce best practice guidance for managing power sources when going to sleep and awakening
- Instruct patients to report any persistent, unexpected audible tones to the VAD team for additional instructions
Update June 2018: Medtronic HeartWare Field Representatives will coordinate with surgeons to arrange for service of patient's HVAD power source components. This will include application of a lubricant to all HVAD power sources. It is expected that this will be a one-time field service.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
The manufacturer, well lead medical co ltd, have identified that certain batches where the oxygen tubing might detach from the connector.There have been no injuries associated with this issue.
Action
Device Technologies is advising users to inspect stock and quarantine remaining stock of the affected batches. Affected stock can be returned to Device Technologies and a credit note issued.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
This recall is being conducted due to the potential for the sterile packaging to be compromised, as a result of holes in the sterile packaging. the use of products with this condition may result in a potentially increased risk for infection. there have been no reports of infection associated with this issue.
Action
Medtronic is advising users to inspect stock and quarantine any remaining units of the affected batches. Affected stock can be returned to Medtronic for credit.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Drager has determined that when the infinity m540 patient monitor with software versions vg4.1 and below is used in combination with the infinity mcable mainstream c02 (m11.1) revision 16 sensor, the infinity m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. should the infinity m540 patient monitor reboot 3 times within a 10 minute period or less, the infinity m540 patient monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.This issue only occurs with infinity cable revision 16. there have been no injuries reported as a result of this issue.
Action
Drager is advising users to discontinue use the Infinity CO2 sensor, revision 16. Drager will be replacing all revision 16 cables with an earlier revision as an interim correction.
A software update will be implemented as a long term correction.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Product complaints received by bard australia reported that the safety sheath covering the scalpel blade (component number in1951) was found in a very low number of lifemed procedure packs as being not engaged, resulting in an exposed blade that could inadvertently lead to a cut during manual handling by health care professionals, especially in circumstances where they are unaware of this anomaly whilst opening the pack.This issue does not impact the sterility of the packs.
Action
Users are being made aware of this issue and asked to take extra care when opening the procedure packs.
Affected units may be returned at the discretion of the customer on a case by case basis.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Cook medical is initiating a recall of the stonebreaker pneumatic lithotripter and associated accessories. the product is intended for reprocessing at the user facility. cook medical has identified a number of issues relating to the instructions for use (ifu) which may affect the sterility of the device.- the interior of the product may not be sterilised to the appropriate sterility assurance level when following the reprocessing instructions provided in the instructions for use. - the co2 cartridge pouch may be susceptible to tearing.- the exhaust line (purchased separately) does not include re-processing instructions.- the o-ring in the handle may swell during use, leading to leakage and loss of power.Potential adverse events that may occur include urinary tract infection (uti), pyelonephritis, and urosepsis and device leaking and loss of power.
Action
Cook Medical is advising all users to cease use and quarantine the affected products. All affected product is to be returned to Cook Medical.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Australasian medical & scientific ltd (amsl) have been made aware that the measurement markings on certain nasogastric tubes may be blurred and illegible which may result in a tube being inserted at an incorrect length in a patient.
Action
AMSL is advising customers to inspect inventory for identified lot numbers and inspect these lots for any units which display blurry or illegible text. Users should quarantine any affected units for return to AMSL and a replacement to be issued.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Biomérieux australia has been advised that the manufacturer, biofire diagnostics, has identified an increased risk of false positive proteus results when the filmarray blood culture identification (bcid) panel is used with bd bactec blood culture bottles with expiration dates of september 30, 2018 and october 31, 2018. it is unknown if subsequent lots of media will also be subject to this risk; however, biofire and bd are continuing to investigate the issue.
Action
bioMérieux is advising customers to verify positive results for Proteus by confirming with another method where BD BACTEC Blood Culture Bottles with expirations on 30/09/2018 and 31/10/2018 have been used due to the BCID Panel detecting nucleic acid from non-viable Proteus.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Radiometer previously informed users that they had received reports that instruments sensitive to electromagnetic interference may be affected by tcm5 measurements (tga ref: rc-2018-rn-00081-1 and rc-2017-rn-01327-1).Radiometer has released the revised version of the instructions for use which includes a separate paragraph in the introduction section under “electromagnetic interference”. this amendment is included from the tcm5 instructions for use, 996-436, version 201801f, pages 5 and 6. the updated ifu mirror the actions for users identified in rc-2018-rn-00081-1.
Action
Radiometer is advising users to discard previous revisions of the Instructions for Use and replace these with the new versions.
Radiometer is working on a solution, which involves a hardware redesign of the TCM5 monitoring system, for this issue. Users will be contacted by their Radiometer representative when the final solution is available.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
G5 mobile receivers manufactured between january 2016 and february 2017 may not adequately complete the power on sequence under specific conditions. specifically, when the receiver is turned on, the green loading bar on the initialization screen becomes stuck with no further progress. the user cannot clear this screen and the receiver cannot be used to track blood glucose values. this is due to a software defect affecting devices produced in the above timeframe, which renders the receiver unusable after shutting it down in a particular sequence. this is a detectable issue for users if they check the screen after turning it on. no adverse health consequences are anticipated if you make sure you have access to an alternative means of monitoring your blood glucose.
Action
Emergo is advising users to contact Australian Medical Scientific (AMSL) to obtain a replacement receiver.
Supplemental instructions will be provided to users as an interim measure to prevent this issue occurring until users receiver an updated receiver.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Siemens healthcare diagnostics has confirmed that some dimension vista diluent lots may have an incomplete slit on the septum in the cap of the vial. a diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the dimension vista system, due to a reduced volume of diluent being pipetted from the vial.There have been no injuries reported as a result of this issue.
Action
Siemens is advising users to inspect stock and discard any remaining stock of the affected lots.
Siemens is not recommending a review of previously generated results.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Stryker has received a report that a hinge pin disassociated from the mako onlay insert extractor. in that reported case, the disassociated hinge pin was discovered prior to the device being used in surgery and a backup device was available and subsequently used to complete the procedure. in the event of an undetected disassociated hinge pin, the potential hazards include the hinge pin being left in the wound or excessive metal wear giving rise to debris. to date, there have been no injuries reported as a result of this issue.
Action
Stryker is advising users to inspect stock and return any remaining units of the affected lot numbers.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Getinge has identified an issue causing failure of the control keypad resulting in the cupola not turning on or off. a review of complaint data has demonstrated that this issue has occurs in 3 different keypad versions. this potential for malfunction is caused by an internal frequency issue of a component on keypads version 1, and by the touch-sensitive technology that was not sensitive enough on versions 2 and 3. the keypads at fault are no longer produced. getinge have implemented a more robust keypad using a different technology. this action is to replace the potentially defective keypads with the new keypad.To date, no injuries as a result of this issue have been reported.
Action
Getinge is advising they will contact affected users to schedule a service to replace any potentially defective keypads with the new keypad.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Philips has identified systems that may have been infected with the "wannacry" ransomware virus before installation. the virus may encrypt files in a way that:- prevents system access; or - a patient undergoing a scan or recently scanned whose results have not been reviewed may require a ct rescan; or- during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real timeto date, there have been no reports of patient harm as a result of this issue.
Action
Philips are advising that they will be contacting users to arrange an appointment for a Field Service Engineer to correct the software on any potentially impacted systems
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Abacus has been advised by immucor (the manufacturer), that as a result of a complaints investigation, it has been determined that the serological group for the b*27:08 allele was incorrectly assigned as bw4. the correct serological group assignment for b*27:08 is bw6. this assignment was part of the 3.29.0 allele database update. immucor confirm that there is no impact to the lifecodes hla-b sso typing kits themselves.Abacus technical support has confirmed that australian customers do not currently utilise this component of the software, however, are rectifying the issue so it does not present a hazard in the future.
Action
Abacus dx is advising that Immucor has created an executable file to correct the serological group assignment for B*27:08 when using the s.29.0 database update, which is available on the Immucor website. Customers are asked to upload this executable file before running LIFECODES HLA-B SSO typing kits.
Instructions for uploading this file to correct the serological group alignment are outlined on the Customer Letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Johnson & johnson medical has been advised that the manufacturer, ethicon, has become aware of reports from customers related to difficulty removing the obturator from the 5mm endopath xcel trocars with optiview technology.To date, no injuries have been reported as a result of this issue.
Action
Johnson & Johnson Medical is advising users to inspect stock for affected product. Users should complete the Response Form provided with the Customer Letter to arrange for return and replacement of affected goods.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Fresenius medical care has been made aware of incidents regarding quality, safety and performance of the 4008 hd bloodlines tubing. the currently supplied roller clamp may cause customers to experience difficulties in handling that might result in excessive force being used to close the clamp causing the roller part to detach. this may cause infusion of saline solution in the event of incorrect use of the roller clamp, if the second clamp present on the arterial line is also damaged or not closed. a number of leakages were reported at several locations on the 4008 bloodline tubing systems. leakages on the bloodlines may cause blood loss into the environment and may lead to air intake into the system. while the air intake is normally detected by the dialysis machine’s air detector, a leakage of blood may not be detected.
Action
Until further investigations are complete, Fresenius recommend that the Instructions for Use in each carton box of the HD bloodlines be followed, namely:
1. Ensure that all caps and connections are secure; and
2. Inspect the extracorporeal circuit for leaks during priming phase and treatment, taking corrective measures (e.g. tightening Luer-Lock connection) or exchanging the bloodline as necessary.
Ensure that no excessive force is applied on the roller clamp on the reinfusion set in order to regulate the flow of fluid through the infusion pathway.
Fresenius are currently investigating and working to address the issues with the tubing.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
An internal technical investigation by oxoid limited, part of thermo fisher scientific, has confirmed that the performance of antibiotic in thermoscientific oxoid ct1412b cpo30 cefpirome may decrease when stored over 2°c after 24 months. the product has a registered shelf life of 36 months. performance remains unaffected throughout shelf life when stored at -20°c to +2°c. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for cefpirome.
Action
Thermo Fisher is advising customers to inspect stock for affected product and remove them from further use. Users should destroy/discard all current and unused stock of the affected batches.