VITEK 2 Gram-negative Susceptibility Cards
BioMérieux is recalling 30+ VITEK 2 susceptibility card variants over risks of quality control failures and false resistant test results.
Review the full list of affected product reference codes on the FDA recall page to determine if your laboratory is using an impacted card. If affected, discontinue use of these cards for the specified antibiotic formulations and contact BioMérieux for further instructions.
Why it was recalled
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.
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-05-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification