Lusys Laboratories, Inc. recalls COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

Recalled March 16, 2022 · FDA recall Z-0718-2022 · Lusys Laboratories

Hazard

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. · FDA Class I

Units

33,955 kits

Sold at

Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing

Description

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Product

COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

Manufacturer(s)

Lusys Laboratories, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →