Zeus Scientific, Inc.: Medical Device Recall in 2020 - (Recall #: Z-3026-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 where there is a suspicion of exposure to human Parvovirus B19.

Product Classification:

Class II

Date Initiated: August 12, 2019

Date Posted: October 7, 2020

Recall Number: Z-3026-2020

Event ID: 86364

Reason for Recall:

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.

Status: Terminated

Product Quantity: 74

Code Information:

Lot 19040014

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated