Individuals should stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test as these tests have not been authorized, cleared or approved by the Food and Drug Administration (FDA).

In a safety communication, the FDA noted that the use of these tests may be associated with an increased risk of false results. These tests were distributed with labels incorrectly indicating that they are authorized by the FDA. The FDA has designated this a Class I recall, the most serious type. 

Empowered Diagnostics is recalling all lot codes of the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, which were distributed between January 1, 2021 and November 11, 2021. There have been at least 284,575 antigen tests and at least 2100 antibody tests recalled in the United States.

To date, there have been no reports of adverse health consequences from use of these tests. Health care providers should consider retesting patients using an FDA authorized SARS-CoV-2 diagnostic test if the antigen test was given less than 2 weeks prior.

Issues related to SARS-CoV-2 testing should be reported to the FDA’s MedWatch Voluntary Reporting Form.

References

  1. Stop using empowered diagnostics COVID-19 tests: FDA safety communication. News release. US Food and Drug Administration. January 28, 2022. Accessed February 2, 2022. https://www.fda.gov/medical-devices/safety-communications/stop-using-empowered-diagnostics-covid-19-tests-fda-safety-communication

2. Empowered Diagnostics recalls COVID-19 tests due to risk of false results. News release. US Food and Drug Administration. January 28, 2022. Accessed February 2, 2022. https://www.fda.gov/medical-devices/medical-device-recalls/empowered-diagnostics-recalls-covid-19-tests-due-risk-false-results