The U.S. Food and Drug Administration has issued a warning about two COVID-19 tests manufactured by Empowered Diagnostics because the tests are not authorized or approved by the FDA, despite labeling that indicates they are.
CovClear COVID-19 Rapid Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid tests have been recalled by Empowered Diagnostics, the FDA said.
The FDA is concerned about the potential for false test results.
RECALL: The @US_FDA has recalled CovClear COVID-19 Rapid Antigen test & ImmunoPass COVID-19 Neutralizing Antibody Rapid Test by Empowered Diagnostics. They are not authorized by FDA, despite the labeling that indicates otherwise. Higher risk of false results…1/2 @LaurelPIO pic.twitter.com/Fo6PuzOijw
— Laurel City OEM (@LaurelCityOEM) January 31, 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 statement said.
he FDA said people who have tested with the recalled Empowered Diagnostic COVID-19 products should talk to their physician if they are concerned about recent results.
Health care providers should consider retesting patients using FDA-authorized COVID-19 testing kits if patients tested with the recalled products within the last two weeks.