Recall alert: FDA announces recall of 3 COVID-19 tests

The Food and Drug Administration has announced the recall of three COVID-19 tests.

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The FDA said the COVID-19 antigen test that uses saliva, the antigen test that uses a nasal swab and the IgG/IgM antibody test made by LuSys Laboratories have been recalled because they have not received emergency use authorization and cannot be legally marketed or distributed in the U.S.

LuSys Laboratories did not provide documentation that they are accurate, meaning that there could be false results or misinterpretation, according to the FDA.

There have not been complaints or reports of injuries or deaths.

There were 164,250 tests distributed from June 1, 2020, through July 21, 2021.

These are the same tests that were included in a “do not use” announcement earlier this year.

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

If you have the recalled tests, the FDA said not to use them and discard, destroy or return them. Consumers can contact LuSys Laboratories by calling 858-733-2128 or by email at

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