Home / Recalls / Medical Devices
Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Recalled December 27, 2023 · FDA recall Z-0602-2024 · Zeus Scientific
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. · FDA Class II
Units
296 kits
Sold at
US States: CA, MA, MI, NJ, NY, TN, UT.
Description
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.
Product
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Manufacturer(s)
Zeus Scientific, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →