Home / Recalls / Zeus Scientific, Inc. / Z-3026-2020

Z-3026-2020 Class II Terminated

Recalled by Zeus Scientific, Inc. — Branchburg, NJ

Recall Details

Product Type: Devices
Report Date: October 7, 2020
Initiation Date: August 12, 2019
Termination Date: May 20, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 74

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.

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.

Distribution Pattern

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

Code Information

Lot 19040014