Date of issue: 28 January 2022

The US Food and Drug Administration (FDA) warns people to stop using Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with markings indicating that they are FDA approved, but none of the tests have been approved, approved, 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 problem as a Class I recall, the most severe form of recall.

Recommendations

Do not use 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 relatives: Talk to your healthcare provider if you have been tested with the CovClear COVID-19 Rapid Antigen Test and you are in doubt about your test results.
  • Healthcare providers and test program organizers: If the antigen test was given less than two weeks ago, you may want to consider testing your patients again 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, there is no need to retest.
  • Report any problems you experience with the CovClear COVID-19 Rapid Antigen Test to the FDA, including suspected false results. See Reporting issues with your test.

ImmunoPass COVID-19 Neutralizing Antibody Rapid Test

  • Test users and relatives: Talk to your healthcare provider if you have been tested with the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test and you are in doubt about your test results.
  • Healthcare providers and test program organizers: If you suspect a recent or previous COVID-19 infection, consider testing your patients again with an FDA-authorized SARS-CoV-2 antibody test.
  • Report any problems you experience with the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test to the FDA, including suspected false results. See Reporting issues with your test.

Test descriptions

  • The CovClear COVID-19 Rapid Antigen Test uses a nasal inoculation 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 fingerprint 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 that the person may have previously been infected with the SARS-CoV-2 virus. Antibody testing should not be used to diagnose or rule out 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 that the person does not have COVID-19, but that the person is actually infected. A false-negative result can lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which can cause human harm, including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when humans 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, measures may not be taken to limit the exposure of an infected person, such as isolating people, restricting contact with family and friends, or restricting access to workplaces.
  • A false positive antigen test result means that the test says that the person has COVID-19, but that they are not actually infected. A false-positive result can lead to a delay in both the correct diagnosis and appropriate treatment of the actual cause of a person’s disease, which may be another life-threatening disease other than COVID-19. False-positive results can also lead to further spread of the SARS-CoV-2 virus when suspected positive people are housed together.

ImmunoPass COVID-19 Neutralizing Antibody Quick Test:

  • A false-negative antibody test result means the test says the person does not have antibodies to the SARS-CoV-2 virus when the person actually has antibodies. False-negative results can cause test users to take fewer precautions to prevent the spread of infection if the test is used inappropriately as evidence that there is no active infection.
  • A false-positive antibody test result means the test says the person has antibodies to the SARS-CoV-2 virus when the person does not actually have antibodies to the SARS-CoV-2 virus. False-positive results may cause test users to take fewer precautions to protect themselves against 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 of these tests as one class I remember, the most serious form of revocation. The FDA is working with Empowered Diagnostics to address these issues. The FDA will continue to keep the public informed of significant new information.

Reporting issues with your test

If you think you have a problem with a SARS-CoV-2 test, the FDA encourages you to do so report the issue through the MedWatch Voluntary Reporting Form.

Healthcare professionals employed by facilities subject to FDA reporting requirements for user facilities should follow the reporting procedures established by their facilities.

Questions?

If you have any questions about this security notice, please email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.