Device recall
Z-2003-2009: Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics…
FDA device recall · Class II · Roche Diagnostics Operations, inc.
Key facts
| Recall number (Z-number) | Z-2003-2009 |
|---|---|
| Recall event | 52724 |
| Product | Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. |
| Product code | GJS |
| Recalling firm | Roche Diagnostics Operations, inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2011 |
| 510(k) numbers | K062925 |
| 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