Lab Alert: FDA Issues Safety Communication about Risk of False Results with the Curative SARS-CoV-2 Test
Summary
CDC Laboratory Outreach Communication System lab alert dated 01/06/2021, addressed to clinical laboratory professionals. It states that 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. It says the test should be performed according to the instructions for use to reduce that risk, and that FDA encourages reporting of adverse events through MedWatch. The page gives an FDA contact for questions and shows a last-reviewed date of January 27, 2023.
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“Lab Alert: FDA Issues Safety Communication about Risk of False Results with the Curative SARS-CoV-2 Test.”
Original at www.cdc.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/cdc-locs-curative-fda-safety-comm-alert-2021-01-06-af037aea7e/
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01/06/2021: Lab Alert: FDA Issues Safety Communication about Risk of False Results with the Curative SARS-CoV-2 Test for COVID-19 Print Related Pages Audience : Clinical Laboratory Professionals Level : Laboratory Alert 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: 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/locs Last Reviewed: January 27, 2023 Source: CDC's Laboratory Outreach Communication System (LOCS)
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