FDA: COVID-19 Test Could Give Inaccurate Results
Agency issues alert about Thermo Fisher's TaqPath genetic test
TUESDAY, Aug. 18, 2020 (HealthDay News) -- A widely used COVID-19 test could produce inaccurate results due to issues with the equipment and software used to run the test, the U.S. Food and Drug Administration warned Monday.
The agency issued the alert about Thermo Fisher's TaqPath genetic test.
The company is working with the FDA "to make sure that laboratory personnel understand the need for strict adherence to the instructions for use," according to a spokeswoman for Thermo Fisher.
The FDA did not reveal how many inaccurate test results there have been.