FDANovember 6, 2020device

Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.

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

The hazard

Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

05172373190

Recall history

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

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