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Zeus Scientific Recalls
4 recalls on record · September 18, 2019 to December 27, 2023 · Medical Devices
Recalls by year
19
20
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 27, 2023Medical DevicesFDA
Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Hazard: 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.
December 27, 2023Medical DevicesFDA
Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Hazard: 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.
October 7, 2020Medical DevicesFDA
Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of
Hazard: 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.
September 18, 2019Medical DevicesFDA
Zeus Scientific, Inc. recalls Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy
Hazard: 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.