Zeus Scientific recalls
Zeus Scientific appears in 4 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 4 |
|---|---|
| Published | 2019-09-18 to 2023-12-27 |
| By agency | FDA Device (4) |
| By classification | Class II (4) |
| By status | ongoing (2), terminated (2) |
| Distribution named in notices | CA, MA, MI, NJ, NY, TN, US, UT |
Recalls
- ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
FDA Device · Class II · 2023-12-27 · Zeus Scientific
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. - ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
FDA Device · Class II · 2023-12-27 · Zeus Scientific
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. - ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodi…
FDA Device · Class II · 2020-10-07 · Zeus Scientific
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, an… - 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
Reason: Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless…