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Roche Diagnostics Operations, Inc. recalls Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination
Recalled December 23, 2020 · FDA recall Z-0634-2021 · Roche Diagnostics Operations
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. · FDA Class II
Units
699 units
Sold at
US Nationwide distribution including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA.
Description
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.
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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →