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

Recall Z-0489-2025 — cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

U.S. FDA — Device Enforcement · United States · 2024-10-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0489-2025
Date of alert
2024-10-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04015630929979
Reported risk: Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
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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