Device recall
Z-1047-2009: AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1047-2009 |
|---|---|
| Recall event | 50816 |
| Product | AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past… |
| Product code | LFZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2010 |
| 510(k) numbers | K953943 |
| FEI number | 1415939 |
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