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

Recall Z-0433-2022 — VIDAS LH, REF 30406-01

U.S. FDA — Device Enforcement · United States · 2021-09-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0433-2022
Date of alert
2021-09-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
bioMerieux, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
03573026156930
Reported risk: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
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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