Biomerieux Inc Recalls

5 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (5)

July 24, 2026
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 resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
Class II
June 4, 2026
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.
Class II
January 5, 2026
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD
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 formulations. Issue may lead to QC failure or false resistant results.
Class II
June 26, 2025
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identifica
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Class II
March 14, 2024
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340;
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 of MIC=0.5, 1, 2.
Class I

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