U.S. Food and Drug Administration (FDA) Safety Communication
The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use and its COVID-19 Test intended for patient care settings due to increased risk of false results.
Recommendations for Home Test Users and Caregivers
- Do not use any Cue Health COVID-19 Tests for Home and OTC Use that you may still have. Dispose of the entire test cartridge in the household trash.
- Talk to your health care provider if you were tested with the Cue Health COVID-19 Test for Home and Over the Counter (OTC) Use, and you are concerned about your results.
- Consider retesting using a different COVID-19 test that received FDA authorization if you tested negative on the Cue Health COVID-19 Test for Home and OTC Use and still have symptoms.
- Report any problems you experience with the Cue Health COVID-19 Test for Home and Over the Counter (OTC) Use to the FDA, including suspected false positive or false negative results. See Reporting Problems with Your Test.
Recommendations for Health Care Providers
- Do not use any Cue Health COVID-19 Tests that you may still have. Dispose of the entire test cartridge in your general waste disposal.
- Consider retesting your patients using a different FDA authorized test if you suspect an inaccurate result was given Cue COVID-19 Test. 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. See Reporting Problems with Your Test.
