LuSys Recalls COVID-19 Tests

3/14//22 — LuSys Laboratories, Inc. is recalling COVID-19 antigen (nasal/saliva) and COVID-19 IgG/IgM antibody tests because they do not have an Emergency Use Authorization (EUA), 510(k) premarket notification, or premarket approval (PMA) and therefore cannot be marketed and distributed in the U.S. The risks include potential false negative, false positive, and misinterpretation of results from these tests. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read the FDA recall notice.