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# Empowered Covid-19 Test Recall is Class 1
- URL: https://www.fdaweb.com/empowered-covid-19-test-recall-is-class-1/
- Published: 2022-02-01T12:00:00.000Z
- Updated: 2026-09-14T17:30:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151056

FDA says the Empowered Diagnostics 12/22/21 recall of all lots of its CovClear Covid-19 rapid antigen test and ImmunoPass Covid-19 neutralizing antibody rapid test is Class 1\. An agency [statement](https://www.fda.gov/medical-devices/medical-device-recalls/empowered-diagnostics-recalls-covid-19-tests-due-risk-false-results?ref=fdaweb.com) says at least 284,575 antigen tests were recalled in the U.S. and at least 2,100 antibody tests. They were all distributed between 1/1/21 and 11/11/21.

Empowered says the tests were recalled because they were distributed with labeling indicating they were authorized by FDA although neither test has been authorized, cleared, or approved for distribution in the U.S.

“FDA is concerned about the potentially higher risk of false results when using unauthorized tests,” the agency notice says. It says there have been no reports of adverse health consequences or deaths from using the tests.