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

Recall Z-0909-2018 — cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

U.S. FDA — Device Enforcement · United States · 2017-07-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0909-2018
Date of alert
2017-07-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04745914001
Reported risk: A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
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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