Device recall
Z-2022-2011: i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for…
FDA device recall · Class II · Abbott Point Of Care Inc.
Key facts
| Recall number (Z-number) | Z-2022-2011 |
|---|---|
| Recall event | 58041 |
| Product | i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess… |
| Product code | JGS |
| Recalling firm | Abbott Point Of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2012 |
| 510(k) numbers | K053110 |
| 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