Reported Feb 11, 2026 · Ongoing

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o…

Biomerieux Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Is this the product you have?

64 of 64 products

Products covered by this recall
Model / numberProduct as published
423701(ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399
423644AST-N402
423645AST-N403
423664AST-N404
423864AST-N405
423869AST-N406
423870AST-N407
423925AST-N409
423936AST-N412
423928AST-N413
423933AST-N414
423934AST-N415
423935AST-N416
423880AST-N417
423948AST-N419
424055AST-N421
424320AST-N428
424321AST-N429
424322AST-N430
424389AST-N433
Lot codes and dates
  • All lot codes of the identified Gram-negative AST test kits.
Amount recalled
2,668,954 total

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:39 PM UTC

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