The U.S. Food and Drug Administration (FDA) issued a warning about two COVID-19 tests made by Empowered Diagnostics because the tests weren’t FDA approved.
The labels stated they are…
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Both of the tests have been recalled by Empowered Diagnostics, the FDA said in an announcement in late January. The recall is listed as a Class 1 recall, which the FDA’s website describes as the most serious type.
“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,” the agency’s statement said. “These tests were distributed with labelling 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.”
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 FDA further said that individuals should not use either test due to the “potentially higher risk of false results when using unauthorized tests.”
“If the antigen test was given less than two weeks ago, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test if you suspect an inaccurate result,” the federal drug regulator said.