The U.S. Food and Drug Administration (FDA) issued a warning about two COVID-19 tests made by Empowered Diagnostics because the tests aren’t approved by the FDA, even though the tests’ labels indicate that they are. Empowered Diagnostics makes the CovClear COVID-19 Rapid Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid tests. Both 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 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 FDA …
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