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Class IIOngoing

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

Recall date · record updated Jul 15, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Biomerieux Inc
Reason
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
International distribution to the countries of Belgium and the Netherlands.
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99213…

Products

  1. VITEK 2 AST-N447 TEST KIT Product reference 424620

    Codes/lots: Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.Quantity: 45,900 cardsRecall no. Z-2715-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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