U.S. FDA says Empowered Diagnostics recalling COVID-19 tests
(Reuters) - Empowered Diagnostics LLC is recalling its COVID-19 tests as they have not been cleared for use in the United States and could potentially...
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(Reuters) - Empowered Diagnostics LLC is recalling its COVID-19 tests as they have not been cleared for use in the United States and could potentially...
The FDA said it is concerned about a "potentially higher risk of false results" from unauthorized tests.
Empowered, a rapid test developer, is recalling the COVID-19 antigen and antibody tests, and the FDA has labeled the recall a Class I, the most serious type.
The FDA said it is concerned about a "potentially higher risk of false results" from unauthorized tests.
The FDA said it is concerned about a "potentially higher risk of false results" from unauthorized tests.