Device recall
Z-0064-2008: Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List…
FDA device recall · Class II · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-0064-2008 |
|---|---|
| Recall event | 39416 |
| Product | Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one… |
| Product code | KXT |
| Recalling firm | Abbott Diagnostic International, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2011 |
| 510(k) numbers | K061249 |
| 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