medical Class II Updated 2020-12-23

Roche Diagnostics Operations, Inc. recalls Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: CRPL3 - lot 42402301
View official government recall

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