Device recall
Z-2175-2008: AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2175-2008 |
|---|---|
| Recall event | 48626 |
| Product | AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium… |
| Product code | LFX |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 5, 2008 |
| 510(k) numbers | K954045 |
| FEI number | 1415939 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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