Device recall
Z-0009-2009: Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0009-2009 |
|---|---|
| Recall event | 48638 |
| Product | Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in… |
| Product code | DDG |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2009 |
| 510(k) numbers | K003064 |
| 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