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

Recall Z-1640-2022 — VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9

U.S. FDA — Device Enforcement · United States · 2022-07-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1640-2022
Date of alert
2022-07-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
bioMerieux, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
03573026553968
Reported risk: There are 7 reported software anomalies that may affect use of the device.
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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