Original Post
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.
Risks of False Test Results
CovClear COVID-19 Rapid Antigen Test:
- A false-negative antigen test result means that the test says the person does not have COVID-19 but the person is actually infected. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities based on these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
- A false-positive antigen test result means that the test says the person has COVID-19 but they are actually not infected. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are housed together.
ImmunoPass COVID-19 Neutralizing Antibody Rapid Test:
- A false-negative antibody test result means that the test says the person does not have antibodies to the SARS-CoV-2 virus when the person actually does have antibodies. False-negative results could lead test users to take fewer precautions to prevent spread of infection if the test is used inappropriately as evidence that there is no active infection.
- A false-positive antibody test result means that the test says the person has antibodies to the SARS-CoV-2 virus, when the person actually does not have antibodies to the SARS-CoV-2 virus. False-positive results could lead test users to take fewer precautions to protect themselves from a future SARS-CoV-2 infection if the test result is interpreted to mean that they have had a previous SARS-CoV-2 infection.
FDA Actions
The FDA has classified the recall for these tests as a Class I recall, the most serious type of recall. The FDA is working with Empowered Diagnostics to resolve these issues. The FDA will continue to keep the public informed of significant new information.
Reporting Problems with Your Test
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.
