LuSys Laboratories Recalls COVID-19 Tests

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CDRH Medical Device Recall

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LuSys Laboratories, Inc Recalls COVID-19 Tests

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.

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If you have questions about this recall, contact LuSys Laboratories by phone at 858-733-2128 or email at