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# FDA Warns Against LuSys Covid Tests
- URL: https://www.fdaweb.com/fda-warns-against-lusys-covid-tests/
- Published: 2022-01-11T12:00:00.000Z
- Updated: 2026-09-14T17:28:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150902

FDA says consumers should stop using the LuSys Laboratories Covid-19 antigen test (nasal/saliva) and Covid-19 IgG/IgM antibody test because their performance has not been adequately established and there is a high risk of false results from the tests. An agency [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) says neither test has been authorized, cleared, or approved by FDA for distribution and use in the U.S.

The notice says the tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals or with the trade name EagleDx. The agency says it believes the tests were distributed for use in laboratories or at-home testing.