Z-0634-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- November 6, 2020
- Termination Date
- October 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 699 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
CRPL3 - lot 42402301