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

On August 17, 2020, the U.S. Food and Drug Administration (FDA) issued a safety letter 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) 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 (online or via email) and the manufacturer. Medical Device Reporting (MDR) is mandatory when a death or serious harm occurs.

Online resources:

• Serology Testing for Coronavirus Disease (COVID-19)
• Clinical Laboratory COVID-19 Response Calls
• CDC’s Laboratory Outreach Communication System (LOCS)
• COVID-19 Information for Laboratories
• CDC COVID-19 website
• Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up

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

This Laboratory Alert was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.