Class II — Zeus Scientific, Inc.
| Recalling firm | ZEUS SCIENTIFIC LLC |
|---|---|
| Registered facility | ZEUS SCIENTIFIC LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer. |
| 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. |
| Quantity | 74 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada. |
| Initiated | 2019-08-12 |
| Classified | 2020-09-29 |
| Terminated | 2022-05-20 |
| Recall number | Z-3026-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zeus Scientific, Inc. (Z-3026-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86364/
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