Device recall
Z-1686-2016: Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA…
FDA device recall · Class II · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-1686-2016 |
|---|---|
| Recall event | 73694 |
| Product | Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection. |
| Product code | LSE |
| Recalling firm | Diamedix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2016 |
| 510(k) numbers | K981812 |
| FEI number | 1044713 |
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