Device recall
Z-3026-2020: ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage…
FDA device recall · Class II · Zeus Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-3026-2020 |
|---|---|
| Recall event | 86364 |
| Product | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19. |
| Product code | MYM |
| Recalling firm | Zeus Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2022 |
| FEI number | 2242436 |
At a glance
- None 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