Device recall
Z-0400-2011: i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole…
FDA device recall · Class II · Abbott Point Of Care Inc.
Key facts
| Recall number (Z-number) | Z-0400-2011 |
|---|---|
| Recall event | 57005 |
| Product | i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. |
| Product code | JBP |
| Recalling firm | Abbott Point Of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2012 |
| 510(k) numbers | K023582 |
| FEI number | 2245578 |
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