Z-0266-2022Class II

Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is...

Name: Z-0266-2022 Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is...
Creator: Roche Diagnostics Operations, Inc.
Published: 2021-10-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2021-10-18 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2021-10-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0266-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-18
Posted: 2021-11-18
Terminated: 2023-05-31
Recalling firm: Roche Diagnostics GmbH
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.
Product code: KQO Automated Urinalysis System
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 636
Distribution: US Nationwide distribution.
Product codes and lots: UDI 04015630932252

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0266-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0266-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18

Product code KQO

K183432Class IIcobas u 601 urinalysis test systemRoche Diagnostics / cleared 2019-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)