01/06/2021: Lab Alert: FDA Issues Safety Communication about Risk of False Results with the Curative SARS-CoV-2 Test for COVID-19

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

On January 4, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communicationexternal icon about the risk of false negative results with the Curative SARS-CoV-2 test for COVID-19.

To reduce the risk of false negative results, the test should be performed according to the instructions for use. Refer to the safety communication for more specific guidance, and please share this message with your partners and colleagues who perform testing for SARS-CoV-2.

 FDA encourages stakeholders to report adverse events or suspected adverse events, including problems with test performance or results, through MedWatchexternal icon, the FDA Safety Information and Adverse Event Reporting program. Please direct any questions to the FDA Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV.

 Online resources:

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

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: January 6, 2021