WASHINGTON (WJLA) — 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.
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The recall is listed as a Class 1 recall, which the FDA says is 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. 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.
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The 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.
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Problems with the CovClear COVID-19 Rapid Antigen test and the ImmunoPass COIVID-19 Neutralizing Antibody Rapid test may be reported to the FDA.
For more information on the recalls, go here.