Cobas u 601 urinalysis test system — Class II medical device recall Z-0266-2022
Terminated recall by Roche Diagnostics Operations, Inc., reported 2021-11-24, distributed nationwide. A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L a
| Recall number | Z-0266-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2021-10-18 |
| Classified | 2021-11-18 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2023-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 636 |
| UPC / GTIN / UDI-DI | 04015630932252 |
| Model numbers | 06334601001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0266-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.