FDAHealthJune 4, 2026
Biomerieux Inc — VITEK 2 AST-N447 TEST KIT Product reference 424620
⚠️ Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- June 4, 2026
International distribution to the countries of Belgium and the Netherlands.
What's affected?
- Product
- VITEK 2 AST-N447 TEST KIT Product reference 424620
- Brand
- Biomerieux Inc
- Lot code
- 0853293604
Additional details
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 45,900 cards.
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