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.

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 roche6051@sedgwick.com. - 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.