Empowered Diagnostics is recalling two Covid-19 tests, CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, as they have been distributed with labels incorrectly indicating that they are US Food and Drug Administration (FDA) authorised.
The FDA has identified the recall of the two products as Class 1, the most serious recall type, as they could potentially lead to a higher risk of false results.
It noted that false results could lead to serious adverse health consequences or death.
