FDA recall, , Moderate risk
VITEK 2 Gram-negative Susceptibility Cards
Issue may lead to QC failure or false resistant results.
Summary by Recall Canary from the FDA notice
What happened
Biomerieux Inc, of Hazelwood, Missouri, voluntarily recalled VITEK 2 Gram-negative Susceptibility Cards containing Polymyxin B (pb02n), Ceftazidime/avibactam (cza02n), Meropenem/Vaborbactam (mev01n), Imipenem (ipm05n), and Imipenem/Relebactam (ipr01n).
The recall was firm initiated and began on January 5, 2026, after the company identified a 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. The issue may lead to QC failure or false resistant results.
The affected cards include product references such as AST-N399 423701, AST-N402 423644, AST-N403 423645, AST-N404 423664, AST-N405 423864, AST-N406 423869, AST-N407 423870, AST-N409 423925, AST-N412 423936, AST-N413 423928, AST-N414 423933, AST-N415 423934, and AST-N416 423935, among others.
The recall was added to the FDA's Enforcement Report on February 2, 2026, and the FDA classified it on the same date. Distribution was nationwide in the US, with the total quantity recalled being 2,668,954 cards. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n);
CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.*** AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491- Lot code
- All lot codes of the identified Gram-negative AST test kits.
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Feb 2, 2026
- Sold in
Worldwide - US Nationwide distribution.
- Recalled by
- Biomerieux IncHazelwood, Missouri
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 98268
- Recall number
- Z-1236-2026
- Quantity recalled
- 2,668,954 total
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Biomerieux Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Biomerieux began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
