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

Recall Z-1408-2021 — VIDAS¿ CMV IgM 30 Tests

U.S. FDA — Device Enforcement · United States · 2021-03-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1408-2021
Date of alert
2021-03-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomerieux Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1008143230
Reported risk: bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
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.

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