Device recall
Z-1047-03: AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and…
FDA device recall · Class II · Abbott Laboratories HPD/ADD
Key facts
| Recall number (Z-number) | Z-1047-03 |
|---|---|
| Recall event | 26530 |
| Product | AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0) |
| Product code | LOK |
| Recalling firm | Abbott Laboratories HPD/ADD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2003 |
| PMA numbers | P820060, P820060S011 |
| FEI number | 1415939 |
At a glance
- None 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