Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious adverse health consequences or death.

Recalled Product 

• Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test
• All lot codes
• Distribution Dates: January 1, 2021 to November 11, 2021
• Devices Recalled in the U.S.:  
  • At least 284,575 antigen tests
  • At least 2,100 antibody tests
• Date Recall Initiated by Firm: December 22, 2021

Test Use

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 antibodies are found 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.

Reason for Recall

Empowered Diagnostics is recalling the 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 for distribution or use in the United States by the FDA. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests.

There have been no reports of adverse health consequences or death from use of these tests.

Who May Be Affected

• People who were tested using these medical devices 
• Health care providers who may have access to and use these tests or whose patients have used these tests
• Organizers of large testing programs, such as in the workplace or schools, who may be using and distributing these tests for diagnostic use
• Distributors

What to Do

On December 20, 2021, Empowered Diagnostics sent customers and distributors a Voluntary Recall e-mail. The e-mail provided the following instructions:

• Stop using and distributing all affected tests.
• Contact the Empowered Diagnostics’ sales representative for disposal and refund instructions.
• E-mail Empowered Diagnostics to confirm receipt of the Voluntary Recall e-mail.

The FDA also recommends:

• Read the FDA’s January 28, 2022 safety communication, “Stop Using Empowered Diagnostics COVID-19 Tests,” for detailed recommendations. 
• For Testing Program Organizers: Notify participants in your testing program to stop using these tests and to perform testing using an FDA-authorized diagnostic test. Antibody tests should not be used to diagnose current infection. For listings of FDA-authorized COVID-19 diagnostic tests, see:
  • FDA-Authorized Molecular Diagnostic Tests for SARS-CoV-2
  • FDA-Authorized Antigen Diagnostic Tests for SARS-CoV-2

Contact Information 

Customers who have questions about this recall should contact Iris Carney at IrisC@EMPDx.net.

Additional Resources:

• Medical Device Recall Database Entry  
• Safety Communication: Stop Using Empowered Diagnostics COVID-19 Tests

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these tests to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.