FDA Provides Update on Empowered Diagnostics’ Recall of its COVID-19 Tests

The FDA has issued an update on Empowered Diagnostics’ Dec. 22, 2021, recall of its CovClear COVID-19 rapid antigen test and the company’s ImmunoPass COVID-19 neutralizing antibody rapid test, deeming it a Class 1 recall because of the risk of serious injury or death.

The tests were distributed with labeling indicating they are authorized by the FDA, when neither test has been authorized, cleared or approved by the agency.

At least 284,575 of the antigen tests and at least 2,100 of the antibody tests were distributed in the U.S. from Jan. 1 to Nov. 11, 2021, the agency said.

The FDA said it is concerned about the potentially higher risk of false results when using unauthorized tests.