Laboratory Alert: FDA Issues Safety Communication About Risk of False Results with the Curative SARS-CoV-2 Test for COVID-19

On January 4, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication 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 MedWatch, 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.

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Please direct questions about this Laboratory Alert to
The Emergency Risk Communication Branch in the Division of Emergency Operations, Center for Preparedness and Response is responsible for the management of all COCA Products. 

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