Roche Diagnostics Operations, Inc. Recall 88879
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.
Roche Diagnostics Operations, Inc. Recall 88879 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0266-2022 |
| Event ID | 88879 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 636 |
| Recall 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. |
| Device Classification | 20211124 |
| Device Code Info | UDI 04015630932252 |
| Center Classification Date | 20211118 |
| Recall Initiation Date | 20211018 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | Letter |
| Similar To |