Recall database

Biomerieux Inc recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2715-2026

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.

Short Incubation Antimicrobial Susceptibility Automated Test System
Process change control

Biomerieux IncMOJul 15, 2026

Class IIOngoingZ-1236-2026

Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidi…

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 formu…

Antimicrobial Susceptibility Test Cards
Under Investigation by firm

Biomerieux IncMOFeb 11, 2026