Stop using these 2 COVID rapid tests, FDA warns. They might give false results.


A certain brand of rapid COVID-19 tests are being recalled because there is a possibility they might give false results, according to the U.S. Food and Drug Administration (FDA).

The company, Empowered Diagnostics, is recalling two tests: the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

The FDA said the recalled tests were not only defective, but they were labeled as if they were approved by the FDA even though they have not been cleared, authorized, or approved by the FDA.

The FDA recommends everyone who used the tests less than a week ago to retest using an FDA-authorized rapid kit. You can find a full list of approved rapid kits here.

If the test was taken more than two weeks ago and you are not showing any symptoms, the agency says it’s not necessary to retest.

“The FDA is concerned about the potentially higher risk of false results when using unauthorized tests,” the agency said, adding it has issued the most serious type of recall for items — a Class I recall.

The CovClear tests use a nasal swab to collect samples for COVID-19 testing while the ImmunoPass test uses a fingerstick blood sample to find COVID-19 antibodies developed from a previous infection.

Both tests are subject to recall because they might give false negative results, leading to inadequate treatment or unintentional spread of the coronavirus.

People who have used the recalled test and believe they had a problem with the test should report it to the MedWatch Online Voluntary Reporting Form.

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How to get a COVID booster shot at CVS, Walgreens or Rite Aid

The omicron variant symptoms to look out for if you are fully vaccinated

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