Home / Recalls / Zeus Scientific, Inc. / Z-0603-2024

Z-0603-2024 Class II Ongoing

Recalled by Zeus Scientific, Inc. — Branchburg, NJ

Recall Details

Product Type
Devices
Report Date
December 27, 2023
Initiation Date
October 31, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
293 kits

Product Description

ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

Reason for Recall

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 Pattern

US States: CA, MA, MI, NJ, NY, TN, UT.

Code Information

UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239

Other recalls by Zeus Scientific, Inc.

  • Z-0602-2024 Class II — ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M (October 31, 2023)
  • Z-3026-2020 Class II — ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: i (August 12, 2019)
  • Z-2494-2019 Class II — Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Softwa (July 22, 2019)