Biomerieux recalls VITEK 2 Gram-negative Susceptibility Cards that may produce false resistant antibiotic results for Enterobacterales and Pseudomonas aeruginosa testing.
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.
Biomerieux is recalling certain VITEK 2 Gram-negative Susceptibility Cards that could give false antibiotic resistance results when testing bacteria. This might lead to incorrect treatment decisions for infections.
These cards might produce false results indicating antibiotic resistance when testing certain bacteria. This could lead to incorrect treatment choices if labs rely on these results for patient care.
Laboratories using these specific VITEK 2 cards for bacterial testing may be affected. Healthcare professionals and labs handling Enterobacterales or Pseudomonas aeruginosa samples are most at risk.
Check for product references like AST-N399 (423701), AST-N402 (423644), or AST-XN09 (423425) on the card. The cards are used for bacterial susceptibility testing in labs.
Look for specific product references listed in the recall notice to identify affected cards.
The recall is for potential quality control failures that could lead to false antibiotic resistance results when testing certain bacteria.
Labs using the specific VITEK 2 Gram-negative Susceptibility Cards with the listed product references for bacterial testing.
No action is required beyond checking product references; the recall does not mandate immediate discontinuation.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1236-2026 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1236-2026 from Biomerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
