Device recall
Z-0597-2011: i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540…
FDA device recall · Class II · Abbott Point Of Care Inc.
Key facts
| Recall number (Z-number) | Z-0597-2011 |
|---|---|
| Recall event | 56832 |
| Product | i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization… |
| Product code | CGA |
| Recalling firm | Abbott Point Of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2013 |
| 510(k) numbers | K001387 |
| 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