from JoAnn- Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication

Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication https://www.fda.gov/medical-devices/safety-communications/stop-using-empowered-diagnostics-covid-19-tests-fda-safety-communication?utm_medium=email&utm_source=govdelivery&fbclid=IwAR1D-4TxqPK1Z5Z4f4CSGn2omh2u_IuKdfO64ZcN3b6mxfjvY5KyLJJaMRY

Date Issued: January 28, 2022

The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests.

Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a Class I recall, the most serious type of recall.

Recommendations

Do not use the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

CovClear COVID-19 Rapid Antigen Test

• Test users and caregivers: Talk to your health care provider if you were tested with the CovClear COVID-19 Rapid Antigen Test and you have concerns about your test results.

• Health care providers and testing program organizers: If the antigen test was given less than two weeks ago, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.

• Report any problems you experience with the CovClear COVID-19 Rapid Antigen Test to the FDA, including suspected false results. See Reporting Problems with Your Test.

ImmunoPass COVID-19 Neutralizing Antibody Rapid Test

• Test users and caregivers: Talk to your health care provider if you were tested with the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test and you have concerns about your test results.

• Health care providers and testing program organizers: Consider retesting your patients using an FDA authorized SARS-CoV-2 antibody test if you suspect a recent or prior COVID-19 infection.

• Report any problems you experience with the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test to the FDA, including suspected false results. See Reporting Problems with Your Test.

Test Descriptions

• The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19.

• The ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies produced by a person’s immune system in response to SARS-CoV-2. If a test detects antibodies, it means the person may previously have been infected with the SARS-CoV-2 virus. Antibody tests should not be used to diagnose or exclude an active COVID-19 infection.