FDAFDA · Food and drugs·Recall number Z-2715-2026
VITEK 2 AST-N447 TEST KIT Product reference 424620
Published July 15, 2026 · Recall initiated: June 4, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- International distribution to the countries of Belgium and the Netherlands.
- Lot
- Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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