Drug recall
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative…
FDA recall event 83806 · Class III · Roche Diagnostics Operations, Inc.
Key facts
| Event ID | 83806 |
|---|---|
| Recall numbers | Z-0152-2020, Z-0153-2020 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Product type | Devices |
| Products | 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 Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to low Quality Control recovery and invalid Calibration. |
| Initiation date | Sep 11, 2019 |
| Report date | Oct 23, 2019 |
| Termination date | Jun 11, 2024 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1823260 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: