Device recall
Z-1581-2013: CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1581-2013 |
|---|---|
| Recall event | 65246 |
| Product | CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. |
| Product code | GJS |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2014 |
| 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