Recalling firm
Biomerieux Inc
Product type
Device
Status
Ongoing
Report date
2026-07-15
Distribution
International distribution to the countries of Belgium and the Netherlands.
Firm state
MO
Product quantity
45,900 cards
Initiated by
Voluntary: Firm initiated
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.
Product description
VITEK 2 AST-N447 TEST KIT Product reference 424620
Code / lot info
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.