Recall Z-0266-2022 ยท KQO Automated Urinalysis System
Roche Diagnostics Operations, Inc.
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,
| Date | Oct 18, 2021 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 636 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183432 | cobas u 601 urinalysis test system Roche Diagnostics, May 7, 2019 |