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U.S. FDA says Empowered Diagnostics recalling COVID-19 tests

Published 01/28/2022, 04:27 PM
Updated 01/28/2022, 04:30 PM
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

(Reuters) - Empowered Diagnostics LLC is recalling its COVID-19 tests as they have not been cleared for use in the United States and could potentially lead to false results, the U.S. Food and Drug Administration (FDA) said on Friday.

The regulator has labeled the recall of the CovClear COVID-19 rapid antigen test and the ImmunoPass COVID-19 neutralizing antibody rapid test as Class 1, or the most serious type of recall.

It cautioned people to stop using the two tests, which have been distributed with labeling that incorrectly indicates that they are authorized by the FDA.

The company could not be immediately reached for comment.

Empowered Diagnostics initiated the recall in December and has pulled back at least 284,575 antigen tests and 2,100 antibody tests in the United States, according to the regulator.

The CovClear test is currently authorized in Canada and the European Union, according to the company's website.

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