Device recall
Z-1797-2010: i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in…
FDA device recall · Class II · Abbott Point of Care Inc.
Key facts
| Recall number (Z-number) | Z-1797-2010 |
|---|---|
| Recall event | 54652 |
| Product | i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's… |
| Product code | JPI |
| Recalling firm | Abbott Point of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2012 |
| 510(k) numbers | K912387 |
| FEI number | 2245578 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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