Device recall
Z-0812-2010: i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product…
FDA device recall · Class III · Abbott Point of Care Inc.
Key facts
| Recall number (Z-number) | Z-0812-2010 |
|---|---|
| Recall event | 53335 |
| Product | i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests… |
| Product code | CGA |
| Recalling firm | Abbott Point of Care Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 8, 2014 |
| 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