Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0634-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 6, 2020

Date Posted: December 23, 2020

Recall Number: Z-0634-2021

Event ID: 86745

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.

Status: Terminated

Product Quantity: 699 units

Code Information:

CRPL3 - lot 42402301

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.

Voluntary or Mandated:

Voluntary: Firm initiated