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Home › FDA recalls › VITEK 2 AST-N447 TEST KIT Product reference 424620
CLASS II · ModerateFDA

Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620

📅 Jun 4, 2026 · 📍 See notice
Recalling company
Biomerieux Inc
Product
VITEK 2 AST-N447 TEST KIT Product reference 424620
Reason
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jun 4, 2026
Reported
Jul 15, 2026
Distribution
International distribution to the countries of Belgium and the Netherlands.
Status
Ongoing
Quantity
45,900 cards
Lot / codes
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Company location
Hazelwood, MO
Recall type
Voluntary: Firm initiated
Recall number
Z-2715-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2715-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.