Device recall
Z-0451-2014: Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540…
FDA device recall · Class II · Abbott Point Of Care Inc.
Key facts
| Recall number (Z-number) | Z-0451-2014 |
|---|---|
| Recall event | 66757 |
| Product | Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat… |
| Product code | GJS |
| Recalling firm | Abbott Point Of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2014 |
| 510(k) numbers | K020355 |
| 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