Zeus Scientific, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0603-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

Product Classification:

Class II

Date Initiated: October 31, 2023

Date Posted: December 27, 2023

Recall Number: Z-0603-2024

Event ID: 93514

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.

Status: Ongoing

Product Quantity: 293 kits

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated