# FDA recall Z-0634-2021

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2020-11-06.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-0634-2021
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-06
- **Report date:** 2020-12-23
- **Termination date:** 2024-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0634-2021

## Citation

> AI Analytics. FDA recall Z-0634-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0634-2021. Source: US FDA. Licensed CC0.

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