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FDA: Stop using this brand of rapid COVID tests

At least 284,575 antigen tests and 2,100 antibody tests from Empowered Diagnostics are being recalled in the U.S.

WASHINGTON — Editor's note: The video above was first published on Jan. 19, 2022. 

The Food and Drug Administration warned people Friday to stop using a specific brand of rapid COVID antigen and antibody tests, saying there could be a higher risk of false results. It comes two weeks after a similar warning about other tests.

Empowered Diagnostics is recalling its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

According to the FDA, the Empowered Diagnostics tests weren't authorized by the FDA, despite labeling that indicated otherwise. The agency said it is concerned about a "potentially higher risk of false results" from unauthorized tests. 

The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect antigens from the virus, the FDA said. The ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a blood sample to detect antibodies from a person's immune response to the virus. Antibody tests like this one show whether a person was previously infected, so they shouldn't be used to diagnose an active COVID-19 case. 

Anyone who received the CovClear COVID-19 Rapid Antigen Test in the last two weeks is urged by the FDA to get tested again.

The tests were distributed from January to November 2021. According to the recall notice, at least 284,575 antigen tests and 2,100 antibody tests are included. The company first started the recall late last month and has alerted customers and distributors via email. According to the company's website, the CovClear test is authorized in Canada for over-the-counter use at home and other non-laboratory sites. 

If you think you had a problem with a COVID-19 test, you can report it through the FDA's website. 

A false negative on an antigen test may tell a person they do not have COVID-19 when they actually do have it, the FDA said. A false positive would mean the person is told they have COVID-19 but really don't.

Conversely, a false negative on an antibody test would mean the person is told they don't have antibodies to the coronavirus but actually do have them. A false positive means the opposite -- the test says they do have the antibodies but really don't.

The FDA issued a similar alert on Jan. 11 for antigen and antibody tests from LuSys Laboratories.