FDA Device recall Z-3026-2020
ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodi…
- FDA Device
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodi… by Zeus Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3026-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-12 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zeus Scientific |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot 19040014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Zeus Scientific
- ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
FDA Device · Class II · 2023-12-27 · Zeus Scientific - ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
FDA Device · Class II · 2023-12-27 · Zeus Scientific - Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl…
FDA Device · Class II · 2019-09-18 · Zeus Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3026-2020%22
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