Biomerieux Recalls
431 recalls on record · October 17, 2012 to July 15, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls API 20 E 25 STRIPS, CATALOG 20100
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
October 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Hazard: Invalid calibrations (out of range high) while using the product.
September 7, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V
Hazard: There are 7 reported software anomalies that may affect use of the device.
August 31, 2022Medical DevicesFDA
bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Hazard: There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
May 18, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VITEK 2 Systems and VITEK 2 with MYLA.
Hazard: Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
February 2, 2022Medical DevicesFDA
Biomerieux Inc recalls API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identifica
Hazard: Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS SARS-COV-2 IgG, Ref 423834-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS SARS-COV-2 IgM, Ref 423833-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS Lyme IgG II (LYM), REF 417401
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS Lyme IgM II (LYM), REF 416436
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS Estradiol II, REF 30431-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS FSH, REF 30407-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS LH, REF 30406-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS RUB IgG (RBG), REF 30226
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS Measles IgG (MSG), REF 30219
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS Mumps IgG (MPG), REF 30218
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS DEX@, Dimer Exclusion II, REF 30455-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS Clostridium Difficile GDH, REF 30125-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
January 5, 2022Medical DevicesFDA
bioMerieux, Inc. recalls VIDAS PRG Progesterone, REF 30409-01
Hazard: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.