CLASS II Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Cobas u 601 urinalysis test system recalled
Roche Diagnostics Operations is recalling Cobas u 601 urinalysis test system, distributed nationwide in the US. The recall was initiated on 18 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0266-2022
- FDA event ID
- 88879
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2021
- FDA classified
- 18 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 18 Oct 2021 | Recall initiated by company | |
| 18 Nov 2021 | Classified by FDA | +31 days |
| 24 Nov 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI 04015630932252
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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