# FDA recall Z-0103-2021

> **Roche Diagnostics Operations, Inc.** · Class III · device recall initiated 2020-08-27.

## Product

Tina-quant Complement C4 ver.2, Catalog 05991994190

## Reason for recall

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

## Distribution

Domestic distribution nationwide.

## Key facts

- **Recall number:** Z-0103-2021
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-27
- **Report date:** 2020-10-21
- **Termination date:** 2024-05-22

- **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-0103-2021

## Citation

> AI Analytics. FDA recall Z-0103-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0103-2021. Source: US FDA. Licensed CC0.

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