FDA: Stop using LuSys Laboratories COVID-19 tests due to potential false results

The Food and Drug Administration Tuesday is advising people to not use COVID-19 tests from LuSys Laboratories because they can produce false results — positive or negative.

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The FDA said in a news release that the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody tests have not been “authorized, cleared, approved by the FDA for distribution or use in the United States.”

The tests may also be sold under the names “Luscient Diagnostics” or “Vivera Pharmaceuticals” or “EagleDx.”

If you either used the tests at home or were tested with them at a lab, speak to your health care provider if you have concerns about your results.

The results could be a false negative, meaning you could have COVID-19 and risk spreading it, or a false positive, meaning you do not have COVID-19.

If you received false results, you can report them to the FDA.

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