Attention: Clinical Laboratories

Please share this announcement with:

  • Medical Director, Laboratory Services
  • Administrative Director and Manager(s), Laboratory Services

Posted 08.18.2020 by: Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)

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.

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