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 | Ongoing |
| Reason | 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. |
| Product | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M |
| Quantity | 296 kits |
| Distribution | US States: CA, MA, MI, NJ, NY, TN, UT. |
| Initiated | 2023-10-31 |
| Classified | 2023-12-21 |
| Recall number | Z-0602-2024 |
| 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-0602-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93514/
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