Device recall
Z-0297-2009: AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM…
FDA device recall · Class III · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-0297-2009 |
|---|---|
| Recall event | 48628 |
| Product | AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose… |
| Product code | KXT |
| Recalling firm | Abbott Diagnostic International, Ltd. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 9, 2011 |
| 510(k) numbers | K953718 |
| FEI number | 2623532 |
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