Z-2715-2026 Class II Ongoing
FDA device recall Z-2715-2026 was initiated by Biomerieux Inc on June 4, 2026 and is designated Class II. Reason for recall: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. The recall status is ongoing. Affected quantity: 45,900 cards.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2026
- Initiation Date
- June 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,900 cards
Product Description
VITEK 2 AST-N447 TEST KIT Product reference 424620
Reason for Recall
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Distribution Pattern
International distribution to the countries of Belgium and the Netherlands.
Code Information
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.