FDA Recalls 2 COVID Tests to Cover National Security Concerns Pertaining to Chinese Data Harvesting.

The US Food and Drug Administration (FDA) has issued a warning about two Empowered Diagnostics COVID-19 tests, claiming that the tests are not FDA-approved despite the fact that the labels claim otherwise. CovClear COVID-19 Rapid Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid tests are manufactured by Empowered Diagnostics. Empowered Diagnostics issued a recall for both tests in late January, according to an FDA notice. The recall has been classified as a Class 1 recall, the most serious sort according to the FDA’s website. “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 … Continue reading FDA Recalls 2 COVID Tests to Cover National Security Concerns Pertaining to Chinese Data Harvesting.