Biomerieux recalls
16 official recalls and safety alerts involving Biomerieux since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Biomerieux or the relevant agency.
- 2026-09-30
USBiomerieux Inc recalls VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False…
FDA · DeviceBiomerieux IncInternational distribution to the countries of Austria, Germany, Luxembourg.Official notice →- 2026-07-15
- US
Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
FDA · DeviceBiomerieux IncInternational distribution to the countries of Belgium and the Netherlands.Official notice → - 2026-02-11
- US
Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam…
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic…
- 2025-10-08
- US
bioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of…
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
FDA · DevicebioMerieux, Inc.International distribution in the countries of Albania, Armenia, Australia,…Official notice → - 2024-05-01
- US
Biomerieux Inc recalls VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF…
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result…
- 2023-03-08
- US
Biomerieux Inc recalls MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and…
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the…
FDA · DeviceBiomerieux IncUS Nationwide distribution to the states of Alabama, California, North…Official notice → - 2023-01-11
- US
Biomerieux Inc recalls PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2022-10-05
- US
bioMerieux, Inc. recalls VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Invalid calibrations (out of range high) while using the product.
FDA · DevicebioMerieux, Inc.Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH,…Official notice → - 2022-09-07
- US
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 V4.8 and V4.9
There are 7 reported software anomalies that may affect use of the device.
FDA · DevicebioMerieux, Inc.International distribution to the countries of Estonia, Bahrain, Pakistan, UK,…Official notice → - 2022-08-31
- US
bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
FDA · DevicebioMerieux, Inc.Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN,…Official notice → - 2022-05-18
- US
bioMerieux, Inc. recalls VITEK 2 Systems and VITEK 2 with MYLA.
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…
FDA · DevicebioMerieux, Inc.U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to…Official notice → - 2022-02-02
- US
Biomerieux Inc recalls API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It…
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
FDA · DeviceBiomerieux IncUS (Domestic) Distribution to states of: AZ, IA, KY, and NY.Official notice → - 2022-01-05
- US
bioMerieux, Inc. recalls VIDAS RUB IgG (RBG), REF 30226
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.
- US
Biomerieux Inc recalls RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
FDA · DeviceBiomerieux IncUS Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA,…Official notice → - 2021-11-24
- US
bioMerieux, Inc. recalls API 50 CH, Model 50300
There is potential to provide an incorrect organism identification.
- 2021-10-20
- US
BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Under certain conditions, there is a risk for a false negative result.
FDA · DeviceBioMerieux SAWorldwide distribution - US Nationwide distribution and the countries of…Official notice →