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FDAJuly 18, 2017device

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

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

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

04745914001050364530010503645369205860636001

Recall history

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

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