Cobas c Bilirubin Total Gen — Class III medical device recall Z-0153-2020
Terminated recall by Roche Diagnostics Operations, Inc., reported 2019-10-23, distributed nationwide. Due to low Quality Control recovery and invalid Calibration.
| Recall number | Z-0153-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-09-11 |
| Classified | 2019-10-16 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2024-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 2,304 units |
| Lot numbers | 36133801 |
| Model numbers | 05795419190 |
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 for recall
Due to low Quality Control recovery and invalid Calibration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0153-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.