ZEUS ELISA Parvovirus B19 IgG Test System — Class II medical device recall Z-0602-2024
Ongoing recall by Zeus Scientific, Inc., reported 2023-12-27, distributed in CA, MA, MI, NJ, NY, TN, UT. The organization completed a product improvement process to the conjugate found within the certain ELISA kits.
| Recall number | Z-0602-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zeus Scientific, Inc., Branchburg, NJ, United States |
| Recall initiated | 2023-10-31 |
| Classified | 2023-12-21 |
| Reported by FDA | 2023-12-27 |
| Distributed | CA, MA, MI, NJ, NY, TN, UT |
| Quantity | 296 kits |
| UPC / GTIN / UDI-DI | 00845533001748, 00845533001755, 00845533001779 |
| Lot numbers | 23030068, 23060217, 23060218 |
Product
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Reason for recall
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
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-0602-2024. 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.