ZEUS ELISA Parvovirus B19 IgM Test System — Class II medical device recall Z-3026-2020
Terminated recall by Zeus Scientific, Inc., reported 2020-10-07, distributed nationwide. FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test
| Recall number | Z-3026-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zeus Scientific, Inc., Branchburg, NJ, United States |
| Recall initiated | 2019-08-12 |
| Classified | 2020-09-29 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2022-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 74 |
| UPC / GTIN / UDI-DI | 00845533001755 |
| Lot numbers | 19040014 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3026-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.