Official recall notice
FDA DeviceClass IINotable
FDA Recall: VITEK 2 AST-N447 TEST KIT Product reference 424620
- Recall date
- 2026-07-15
- Brand
- Biomerieux Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Product description
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Affected products
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.