FDA Device recall Z-0153-2020
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bi…
- FDA Device
- Class III
- terminated
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class III recall of Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bi… by Roche Diagnostics Operations, citing due to low Quality Control recovery and invalid Calibration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0153-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-11 |
| Published | 2019-10-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Reason
Due to low Quality Control recovery and invalid Calibration.
Identifiers
| code_info | Lot # 36133801 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0153-2020%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.