FDAClass IIFebruary 11, 2026

VITEK 2 Gram-negative Susceptibility Cards Containing o recall

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o…

Why was VITEK 2 Gram-negative Susceptibility Cards Containing o 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot codes of the identified Gram-negative AST test kits.

Product
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o…
Recalling firm
Biomerieux Inc
Quantity
2,668,954 total
Distribution
Worldwide - US Nationwide distribution.
Recall date
February 11, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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