Device recall
Z-1447-2012: ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate…
FDA device recall · Class II · Abbott Laboratories Inc.
Key facts
| Recall number (Z-number) | Z-1447-2012 |
|---|---|
| Recall event | 50072 |
| Product | ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated AST) assay is used for the quantitation of asparate aminotransferse in human serum or plasma |
| Product code | CIT |
| Recalling firm | Abbott Laboratories Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2012 |
| 510(k) numbers | K071525 |
| FEI number | 2018433 |
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