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

Recall Z-0675-2018 — Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

U.S. FDA — Device Enforcement · United States · 2017-07-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0675-2018
Date of alert
2017-07-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05641446001
Reported risk: A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
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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