bioMérieux recalls
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for bioMérieux and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-09-30FDA-DeviceClass IIBiomerieux VITEK 2 test kit recalled for false resistance results
Some units of the Biomerieux VITEK 2 AST-N461 test kit used to determine antibiotic susceptibility in gram-negative bacteria have damaged card pouches. This damage can cause the test to report false resistant results, which may lead to use of less effective antibiotics or unnecessary antibiotic combinations.
- 2026-02-11FDA-DeviceClass IIStop using affected VITEK 2 susceptibility cards
Biomerieux VITEK 2 Gram-negative Susceptibility Cards used to test bacterial resistance to certain antibiotics may produce incorrect results or fail quality control checks. The affected cards test bacteria such as E. coli and Pseudomonas aeruginosa against five antibiotic types. Inaccurate results could lead to inappropriate treatment decisions.
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