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FDADecember 18, 2017device

c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692

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

The hazard

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

0474592200105036348001058606520010474592269205036348692

Recall history

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

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