FDA recall Z-0602-2024

Zeus Scientific, Inc. · Class II · device

Product

ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M

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

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

Key facts

Status
Ongoing
Initiation date
2023-10-31
Report date
2023-12-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Branchburg, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0602-2024