Class II

Medical Device Recall: VITEK 2 AST-N447 TEST KIT Product reference 424620

Biomerieux Inc · June 4, 2026

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

International distribution to the countries of Belgium and the Netherlands.

Quantity Affected

45,900 cards

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2715-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.