FDADecember 14, 2018device

cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to measure lipoprotein in seru...

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

The hazard

COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

0540147019004657594190

Recall history

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

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