FDA warns against using recalled at-home COVID-19 tests

According to the FDA, “Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.”

News 12 Staff

Jan 31, 2022, 11:14 PM

Updated 867 days ago

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The Food and Drug Administration on Friday warned against using two at-home COVID-19 tests that can produce false negative or false positive results.
According to the FDA, “Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.”
On Jan. 28, the FDA posted on its website a release headlined, “Stop Using Empowered Diagnostics COVID-19 Tests” which said in part:
“These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests.”
The FDA recommends reaching out to a doctor immediately if the tests were recently relied on for COVID-19 results.


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