Device recall
Z-0930-2011: i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2…
FDA device recall · Class II · Abbott Point of Care Inc.
Key facts
| Recall number (Z-number) | Z-0930-2011 |
|---|---|
| Recall event | 56403 |
| Product | i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance. |
| Product code | CHL |
| Recalling firm | Abbott Point of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2011 |
| 510(k) numbers | K940918 |
| FEI number | 2245578 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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