FDADecember 14, 2018device

COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number :20767107322 - Product Usage: Tin...

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

03032566122044696581900326399119020767107322

Recall history

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

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