Device recall
Z-0103-2021: Tina-quant Complement C4 ver.2, Catalog 05991994190
FDA device recall · Class III · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-0103-2021 |
|---|---|
| Recall event | 86406 |
| Product | Tina-quant Complement C4 ver.2, Catalog 05991994190 |
| Product code | DBI |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 22, 2024 |
| 510(k) numbers | K012359 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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