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# LuSys Labs Covid Tests Recall Class 1
- URL: https://www.fdaweb.com/lusys-labs-covid-tests-recall-class-1/
- Published: 2022-03-15T12:00:00.000Z
- Updated: 2026-09-14T17:36:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151367

FDA has classified as Class 1 a LuSys Laboratories recall of its Covid-19 antigen tests (nasal/saliva) and Covid-19 IgG/IgM antibody tests because they do not have an Emergency Use Authorization, 510(k), or PMA and therefore cannot be legally marketed and distributed in the U.S. The recall follows an FDA [safety communication](https://www.fda.gov/medical-devices/safety-communications/stop-using-lusys-laboratories-covid-19-tests-fda-safety-communication?utm%5Fmedium=email&utm%5Fsource=govdelivery) earlier this year that advised against their use because their performance has not been adequately established and there is a high risk of false results from the tests.