FDAJuly 18, 2017device

cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

05964067001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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