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COVID_19 test tubes

FDA Advises Labs, Healthcare Providers to Stop Using Certain COVID-19 Tests

June 23, 2020

The FDA said clinical laboratories and healthcare providers should avoid using dozens of unauthorized COVID-19 serological tests.

The agency said the 45 listed tests should not be distributed until Emergency Use Authorization (EUA) applications are submitted, noting many manufacturers had failed to submit the required applications, while others had voluntarily withdrawn their EUA applications.

Laboratories and healthcare providers should assess whether results generated using the tests were possibly incorrect and whether patients should be retested with an authorized test, the agency said.

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