(ABC4) – As COVID-19 tests become more prevalent, some, which have not been FDA approved have slipped through the cracks, and are now being recalled.

On Friday, the FDA issued a Class 1 recall on two COVID-19 tests. They say Class 1 is the most serious recall there is.

The FDA is urging the public to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

Both tests were distributed with labeling indicating that they were 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 tests were distributed from January 1, 2021, to November 11, 2021.

Here is a list of those 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

According to the FDA’s website, 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.

The FDA is concerned about the potentially higher risk of false results when using unauthorized tests like the two that are now being recalled.