Device recall
Z-2494-2019: Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File…
FDA device recall · Class II · Zeus Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-2494-2019 |
|---|---|
| Recall event | 83426 |
| Product | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl… |
| Recalling firm | Zeus Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2020 |
| FEI number | 2242436 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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