Empowered Diagnostics has recalled the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.
The problem, the FDA said, is that the tests have not been approved by the agency for distribution in the United States. “The FDA is concerned about the potentially higher risk of false results when using unauthorized tests,” the agency said in a safety communication.
The FDA said it recommends that healthcare providers consider retesting patients if the CovClear COVID-19 Rapid Antigen Test was given less than two weeks ago. “If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest,” the FDA added.
A false-negative antigen test result means that the test says the person does not have COVID-19 but the person is actually infected. A false positive test result means that the test says the person has COVID-19 but they are actually not infected.
Similarly, a false-negative antibody test result means that the test says a person does not have antibodies to the SARS-CoV-2 virus when the person actually does have antibodies. A false-positive antibody test means just the opposite: the test says a person has antibodies to SARS-CoV-2 when they do not.
