Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M

Recall date

October 31, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0602-2024

FDA classification

Class II

Brand / firm

Zeus Scientific, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M