# FDA recall Z-0266-2022

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2021-10-18.

## Product

Cobas u 601 urinalysis test system, Catalog number 06334601001  The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity.

## Reason for recall

A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0266-2022
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-18
- **Report date:** 2021-11-24
- **Termination date:** 2023-05-31

- **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-0266-2022

## Citation

> AI Analytics. FDA recall Z-0266-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0266-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*