Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1464-2024 — VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF

U.S. FDA — Device Enforcement · United States · 2024-03-14 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1464-2024
Date of alert: 2024-03-14
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Biomerieux Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 3573026490720

Reported risk: Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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