Device recall
Z-0634-2021: Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-0634-2021 |
|---|---|
| Recall event | 86745 |
| Product | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers. |
| Product code | DCN |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2024 |
| 510(k) numbers | K083444 |
| 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