Provided by Prince William County Office of Communications
The FDA issued a warning to the public to stop using Empowered Diagnostics COVID-19 Tests. Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the 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 U.S. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests, and has identified this issue as a class I recall, the most serious type of recall.
