08/18/2020: Laboratory Alert: FDA Issues Safety Letter about Thermo Fisher Scientific TaqPath COVID-19 Combo Kit

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Subject: Laboratory Alert: FDA Issues Safety Letter about Thermo Fisher Scientific TaqPath COVID-19 Combo Kit

Level: Laboratory Alert

On August 17, 2020, the U.S. Food and Drug Administration (FDA) issued a safety letterexternal icon about the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit. On August 5, 2020, Thermo Fisher issued a customer letter in response to reports of suspected false positive results associated with the TaqPath assay. The letter listed the immediate actions end users should take to mitigate the risk of false positives. The FDA safety letter states that laboratory professionals who use the TaqPath assay, but did not receive this communication, should contact Thermo Fisher to obtain the customer letter and request to receive future updates.

For laboratories using any Emergency Use Authorization (EUA)external icon assay, it is a best practice (and required under some letters of authorization) to report any suspected instances of false positive or false negative results to FDA (onlineexternal icon or via email) and the manufacturer. Medical Device Reporting (MDR)external icon is mandatory when a death or serious harm occurs.

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If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: August 18, 2020