Cobas u 601 urinalysis test system, Catalog number… recallZ-0266-2022 · Roche Diagnostics Operations, Inc. · initiated Oct 18, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
On October 18, 2021, the firm, Roche, sent "URGENT MEDICAL DEVICE CORRECTION" letters to affected consignees. Customers were notified of the potential for false negative nitrite test results with elevated endogenous creatinine concentrations. Customers were provided with an amended cobas u pack method sheet that provides the updated interference claim for endogenous creatinine. Nitrite testing is commonly included in the process of diagnosing urinary tract infections. In case of false negative nitrite results, particularly in asymptomatic patients or patient with nonspecific symptoms, further diagnostic measures in urine might be skipped, resulting in an increased potential risk for disease progression and complications of UTI. Actions required: - Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. - Review the updated cobas u pack method sheet included with the letter and update your laboratory's procedures, if needed. - Complete and return the customer response form via email to [email protected]. - File the recall notice for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Recall details
- Recall number
- Z-0266-2022
- Status
- Terminated
- Initiated by the company
- Oct 18, 2021
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 636
- Product code
- KQO
- FDA submissions
- K183432
- Distribution
- US Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
UDI 04015630932252
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- cobas u pack 06334601001Roche Diagnostics GmbH · METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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