Biomerieux, Inc.
Durham, NC
This page shows every FDA and USDA recall linked to Biomerieux, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
78
Total Recalls
2002
First Recall
2025
Most Recent
VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n.
VITEK 2 is an automated sy...
Sep 29, 2025
· Device
Open, Classified
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Jul 20, 2022
· Device
Open, Classified
VITEK 2 / MYLA
VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03
MYLA Software ver...
Jul 13, 2022
· Device
Open, Classified
VITEK 2 Systems and VITEK 2 with MYLA.
Mar 29, 2022
· Device
Open, Classified
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Mar 14, 2022
· Device
Open, Classified
API 50 CH, Model 50300
Sep 30, 2021
· Device
Terminated
VIDAS RUB IgG (RBG), REF 30226
Sep 22, 2021
· Device
Open, Classified
VIDAS PRG Progesterone, REF 30409-01
Sep 22, 2021
· Device
Open, Classified
VIDAS Measles IgG (MSG), REF 30219
Sep 22, 2021
· Device
Open, Classified
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
Sep 22, 2021
· Device
Open, Classified
VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
Sep 22, 2021
· Device
Open, Classified
VIDAS LH, REF 30406-01
Sep 22, 2021
· Device
Open, Classified
VIDAS FSH, REF 30407-01
Sep 22, 2021
· Device
Open, Classified
VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
Sep 22, 2021
· Device
Open, Classified
VIDAS Lyme IgG II (LYM), REF 417401
Sep 22, 2021
· Device
Open, Classified
VIDAS Lyme IgM II (LYM), REF 416436
Sep 22, 2021
· Device
Open, Classified
VIDAS SARS-COV-2 IgM, Ref 423833-01
Sep 22, 2021
· Device
Open, Classified
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
Sep 22, 2021
· Device
Open, Classified
VIDAS Estradiol II, REF 30431-01
Sep 22, 2021
· Device
Open, Classified
VIDAS Clostridium Difficile GDH, REF 30125-01
Sep 22, 2021
· Device
Open, Classified
VIDAS Mumps IgG (MPG), REF 30218
Sep 22, 2021
· Device
Open, Classified
VIDAS SARS-COV-2 IgG, Ref 423834-01
Sep 22, 2021
· Device
Open, Classified
VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software,...
Feb 5, 2020
· Device
Terminated
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zeb...
Jan 24, 2020
· Device
Terminated
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Dec 10, 2019
· Device
Terminated
Biomerieux Vitek 2 Test kit
VITEK 2 is an automated system consisting of instruments, software and reagent c...
Mar 15, 2019
· Device
Terminated
VITEK 2 AST-N351 Test Kit
Dec 13, 2018
· Device
Terminated
VITEK 2 Systems Software Version 9.01 Update Kit.
Nov 13, 2018
· Device
Terminated
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products:
Catalog...
Oct 22, 2018
· Device
Terminated
bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
Oct 8, 2018
· Device
Terminated
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS Gene...
Aug 30, 2018
· Device
Terminated
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae agai...
Aug 13, 2018
· Device
Terminated
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae agai...
Aug 13, 2018
· Device
Terminated
BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware
Product Usage:
The BacT/ALERT VIRTU Microbial De...
Jun 27, 2018
· Device
Terminated
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware
Product Usage:
The BacT/ALERT VIRTU Microb...
Jun 27, 2018
· Device
Terminated
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware
Product Usage:
The BacT/ALERT VIRTU Microbial De...
Jun 27, 2018
· Device
Terminated
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*)
Product Usage:
the Quality Control...
May 9, 2018
· Device
Terminated
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*)
Product Usage:
the Quality Con...
May 9, 2018
· Device
Terminated
VIDAS LH, Reference Numbers 30406 and 30406-01.
Poduct Usage:
VIDAS LH is an automated quantitative test for...
Mar 1, 2018
· Device
Terminated
VIDAS Testosterone, Ref 30418
Jun 29, 2017
· Device
Terminated
eMAG System, Ref 418591
It is an In Vitro Diagnostic Medical device intended for the automated isolation (pur...
Apr 10, 2017
· Device
Terminated
BacT/ALERT FA, bioMrieux, Inc.,
Product Usage:
BacT/ALERT Culture Bottles are used with the BacT/ALERT Microb...
Dec 24, 2015
· Device
Terminated
BacT/ALERT SN, bioMrieux, Inc.
Product Usage:
BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbi...
Dec 24, 2015
· Device
Terminated
MYLA CLI V3.X TO V4.1 ML350 SERVER
Product Usage:
MYLA is a computer application (Middleware) based on Web 2....
Nov 3, 2015
· Device
Terminated
MYLA MASTER DVD V4.1 CLI
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technolo...
Nov 3, 2015
· Device
Terminated
MYLA MASTER DVD 3.2 CLI DL380
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 tec...
Nov 3, 2015
· Device
Terminated
MYLA CLINIC PATCH 3.2.0 CD
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 techno...
Nov 3, 2015
· Device
Terminated
MYLA CLI V3.X TO V4.1 DL380 SERVER
Product Usage:
MYLA is a computer application (Middleware) based on Web 2....
Nov 3, 2015
· Device
Terminated
MYLA MASTER DVD V4.0 CLI
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technolo...
Nov 3, 2015
· Device
Terminated
MYLA CLINIC PATCH 3.3.0 CD
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 techno...
Nov 3, 2015
· Device
Terminated