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Open, Classified

VITEK 2 AST-N447 TEST KIT Product reference 424620

FDA Recall Z-2715-2026 · Posted 2026-07-09

Recalling FirmBiomerieux Inc
Recall StatusOpen, Classified
Product CodeLON
Date Initiated2026-06-04
Product Quantity45,900 cards

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.

Firm Action

Firm began notifying customers on June 4, 2026. Customers are instructed to dispose of pouches from the affected lot (Ref 424620, Lot 0853293604). Customer may choose to inspect each pouch in their inventory and only dispose of those with "P7" on the label, or they may choose to dispose of all cards from Lot 0853293604 in their inventory. Based on individual customer policy, customers may wish to perform retrospective review of resistant results. Customers should distribute the information to all appropriate personnel in their laboratory. If product was transferred or further distributed, customer should notify downstream users/accounts.

Root Cause

Process change control

Distribution Pattern

International distribution to the countries of Belgium and the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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