LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA

LuSys Laboratories recalled these tests because they do not have an EUA, 510(k), or PMA and therefore cannot be legally marketed and distributed in the U.S.