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

Recall Z-0094-2017 — Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analy

U.S. FDA — Device Enforcement · United States · 2016-07-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0094-2017
Date of alert: 2016-07-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Roche Diagnostics Operations, Inc.
Product category: device
Product type: Devices

Reported risk: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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