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FDA: Do Not Use Cue Health's Covid-19 Tests Due to Risk of False Results
The FDA is concerned about the risk of false results with Cue Health’s COVID-19 tests as several changes have been made to the tests without FDA review and thes
If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest. Report any problems you experience with the Cue Health COVID-19 Test to the FDA, including suspected false results. The FDA issued Emergency Use Authorizations (EUAs) to Cue Health for two COVID-19 tests, both of which are intended to detect genetic material from SARS-CoV-2 virus in the nostrils.
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