Device recall
Z-0716-2013: Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI)…
FDA device recall · Class II · Abbott Point of Care Canada Limited
Key facts
| Recall number (Z-number) | Z-0716-2013 |
|---|---|
| Recall event | 64043 |
| Product | Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial… |
| Product code | MMI |
| Recalling firm | Abbott Point of Care Canada Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2013 |
| 510(k) numbers | K031739 |
| FEI number | 3005643513 |
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