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
| Model / number | Product as published |
|---|---|
423701 | (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 |
423644 | AST-N402 |
423645 | AST-N403 |
423664 | AST-N404 |
423864 | AST-N405 |
423869 | AST-N406 |
423870 | AST-N407 |
423925 | AST-N409 |
423936 | AST-N412 |
423928 | AST-N413 |
423933 | AST-N414 |
423934 | AST-N415 |
423935 | AST-N416 |
423880 | AST-N417 |
423948 | AST-N419 |
424055 | AST-N421 |
424320 | AST-N428 |
424321 | AST-N429 |
424322 | AST-N430 |
424389 | AST-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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