Device recall
Z-0182-2013: West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155…
FDA device recall · Class III · Focus Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0182-2013 |
|---|---|
| Recall event | 63387 |
| Product | West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively… |
| Product code | NOP |
| Recalling firm | Focus Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 4, 2012 |
| 510(k) numbers | K031953 |
| FEI number | 2023365 |
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