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Laboratory Alert: FDA Issues Safety Communication About Risk of False Results with the Curative SARS-CoV-2 Test for COVID-19 |
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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.
Online resources:
Please direct questions about this Laboratory Alert to LOCS@cdc.gov. |
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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. For information about this update or other clinical issues, or to send your feedback, please contact us at coca@cdc.gov CDC Clinician Outreach and Communication Activity Facebook page—connect with COCA on Facebook Clinician Outreach and Communication Activity—resources for healthcare providers COCA RSS Feed—subscribe to be notified of conference calls, updates, and CDC guidance for health providers Crisis & Emergency Risk Communication Training—training program that draws from lessons learned during public health emergencies, and incorporates best practices from the fields of risk and crisis communication Health Alert Network—CDC's primary method of sharing cleared information about urgent public health incidents with public information officers; federal, state, territorial, and local public health practitioners; clinicians; and public health laboratories |
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