FDA warns providers of 2 unauthorized COVID-19 tests

The FDA is warning healthcare providers and the public to stop using two COVID-19 rapid tests distributed with a label falsely indicating they were authorized by the agency.

The Jan. 28 warning applies to CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. 

Neither test has been authorized, cleared or approved by the FDA for use in the U.S. Empowered Diagnostics, the tests' maker, issued a Class I recall for the tests, the most serious type. 

The FDA said clinicians should consider retesting any patients given either rapid diagnostic test less than two weeks ago due to the risk of false results. 

Learn more here.


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