Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication | FDA

Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication | FDA: These tests have not been authorized, cleared, or approved. The FDA is concerned about the higher risk of false results when using these tests.

Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a Class I recall, the most serious type of recall.  

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