3 COVID-19 tests recalled after FDA warns about ‘high risk’ of false results
A woman takes a swab as part of the COVID-19 antigen rapid test.On Monday, January 3, 2021, in Edmonton, Alberta, Canada. (Photo by Artur Widak/NurPhoto via Getty Images)
The maker of a certain brand of COVID-19 tests has issued a recall because the tests are not authorized, cleared or approved by the U.S. Food and Drug Administration (FDA).
LuSys Laboratories recalled three test types: a saliva antigen test, a nasal antigen test and an IgG/IgM antibody test.
These tests were at the center of an FDA safety memo earlier this year, in which the agency warned people to stop using LuSys Laboratories’ tests because there was likely a high risk of false results.
The FDA said the company did not provide appropriate validation data to show that the tests can perform accurately, meaning "there is a risk of potential false negative, false positive, and misinterpretation of results from these tests."
RELATED: 2nd round of free at-home COVID tests available now, White House says
The FDA believes these tests were distributed for use in laboratories and for at-home testing. The FDA said the tests were distributed from June 2020 through July 21, 2021.
If you have the tests at home or in your laboratory, the FDA says to stop use immediately. The FDA further says to discard, destroy or return all the tests manufactured or distributed by LuSys Laboratories, Inc., a.k.a. Luscient Diagnostics LLC.
If you are in need of at-home COVID-19 tests, the second round of four tests per household is available now to order from the government.
LINK: You can see a list here of at-home over-the-counter COVID-19 diagnostic tests that are authorized by the FDA.
This story was reported from Detroit.