Branchburg, NJ, United States
Zeus Scientific, Inc. recalls
3 recalls recorded since 2018, most recently on 31 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 October 2023
- 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.
- Distribution
- US States: CA, MA, MI, NJ, NY, TN, UT.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0603-2024, Z-0602-2024
- ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
- ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Terminated Class II Medical devices
- Recall started
- 12 August 2019
- Terminated
- 20 May 2022
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3026-2020
- 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 whe
Terminated Class II Medical devices
- Recall started
- 22 July 2019
- Terminated
- 21 May 2020
- 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 of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.
- Distribution
- US nationwide distribution in the states of CA, CT, FL, KY, IN, MA, MI, NY, NJ, NH, OH, PA, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2494-2019
- Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.