Device recall
Z-0153-2020: Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In…
FDA device recall · Class III · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-0153-2020 |
|---|---|
| Recall event | 83806 |
| 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. |
| Product code | CIG |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 11, 2024 |
| 510(k) numbers | K131544 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database