Device recall
Z-2574-2018: Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use…
FDA device recall · Class III · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-2574-2018 |
|---|---|
| Recall event | 80441 |
| Product | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640 |
| Product code | GNP |
| Recalling firm | Diamedix Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| 510(k) numbers | K981831 |
| 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