FDA Device recall Z-0266-2022
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine…
- FDA Device
- Class II
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II 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… by Roche Diagnostics Operations, citing 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 creatini….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0266-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-18 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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.
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.
Identifiers
| code_info | UDI 04015630932252 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.