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

Recall Z-2362-2019 — Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

U.S. FDA — Device Enforcement · United States · 2019-07-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2362-2019
Date of alert
2019-07-16
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)
05031656160
Reported risk: Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
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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