Lower riskMedical device recall · FDA · Published October 18, 2021
Roche Cobas U 601 Urinalysis System Recall: False Negative Nitrite Risk
Roche recalls Cobas U 601 urinalysis test systems with potential false negative nitrite results at high creatinine levels. Affected units may require testing adjustments.
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.
“Roche Cobas U 601 Urinalysis System Recall: False Negative Nitrite Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61663-roche-cobas-u-601-urinalysis-system-recall-false-negative-nitrite. Based on FDA recall #Z-0266-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2022%22&limit=1).
Roche Diagnostics Operations, Inc. recalled the cobas u 601 urinalysis test system on Oct. 18, 2021, due to a risk of false negative nitrite results when creatinine levels are high, according to the FDA. The agency announced the Class II recall under number Z-0266-2022.
How to tell if you have it
Brand: Roche
Product: cobas u 601 urinalysis test system
Catalog number: 06334601001
UDI: 04015630932252
Units affected: 636
The hazard
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.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls since July 2, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall on Jan. 20, 2026, and the Roche Elecsys Anti-TSHR Assay Recall on Nov. 21, 2025. Other recent recalls of similar products include the Siemens Atellica CH Urine Albumin Recall (July 6, 2026), the Siemens Atellica CH Urine Albumin Recall (Jan. 20, 2026), and the Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Check for the Cobas U 601 urinalysis test system with catalog number 06334601001. The product includes the cobas u 601 urine analyzer and cobas u pack. The unique device identifier (UDI) is 04015630932252.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number 06334601001 and unique device identifier (UDI) 04015630932252 to confirm if your unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0266-2022 (October 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0266-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.