Device recall
Z-2222-2009: Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2222-2009 |
|---|---|
| Recall event | 51275 |
| Product | Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP). |
| Product code | LOJ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2010 |
| PMA numbers | P820060, P820060S008 |
| 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