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IPFS News Link • Testing

These coronavirus rapid tests could give false results, says FDA: Stop using them

• https://www.silive.com By Annalise Knudson

The FDA says to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling that indicates they are authorized by the FDA — but the FDA says neither test has been authorized, cleared, or approved by the agency for distribution or use in the United States.

The agency said it's concerned about the potentially higher risk of false results when using unauthorized tests.

Therefore, Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. The FDA identified this as a Class I recall, the most serious type of recall.

The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect proteins from the virus that causes the coronavirus. The FDA is concerned this rapid test could have given false-negative or false-positive antigen test results.


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