FreshRecalls

FDAClass II · Medical device · Recalled July 15, 2026

VITEK 2 AST-N447 TEST KIT Product reference 424620 recall — Biomerieux Inc

Hazard: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2715-2026
Brand
Biomerieux
Classification
Class II
Units affected
45,900 cards
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

VITEK 2 AST-N447 TEST KIT Product reference 424620

Affected products

Companies & origin

Recalling firm location
Hazelwood, MO, United States
Firm address
595 Anglum Rd, N/A, 63042-2320

Identifying details (verbatim from the notice)

Product codes / lots
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Distribution
International distribution to the countries of Belgium and the Netherlands.
Firm notified the public via
Letter
FDA event ID
99213
Recall initiated
June 4, 2026
FDA classified
July 9, 2026
FDA report date
July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 10:00 PM UTC.

Report a data error on this page