FDA Stop Use Order for LuSys Lab COVID-19 Test

1/11/22 — The FDA is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. Read the FDA safety communication.