TemporaryFDAOngoing
Can cause harm that is usually temporary.
VITEK 2 AST-N447 TEST KIT Product reference 424620
Check the device or its packaging for
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
- Why
- Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
- Distributed
- International distribution to the countries of Belgium and the Netherlands.
- Company
- Biomerieux Inc
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2715-2026 · retrieved 9 July 2026
Read the official notice