FDA Device recall Z-0602-2024
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M by Zeus Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0602-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-31 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zeus Scientific |
| Distribution | CA, MA, MI, NJ, NY, TN, UT |
Product
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
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.
Identifiers
| code_info | UDI: (01)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)…UDI: (01)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)23060218; Lot Numbers: 23030068 23060217 23060218 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0602-2024%22
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