Lusys Laboratories, Inc. recalls COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 Ig
Recalled Product
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
View official government recall
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