Device recall
Z-1500-2012: AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay…
FDA device recall · Class III · Zeus Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-1500-2012 |
|---|---|
| Recall event | 61646 |
| Product | AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous… |
| Product code | LJY |
| Recalling firm | Zeus Scientific, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 3, 2013 |
| 510(k) numbers | K961204 |
| FEI number | 2242436 |
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