FDA warns NOT to use Cue Health COVID-19 tests
On May 13, 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication warning that Cue Health’s COVID-19 tests should NOT be used due to increased risk of false results. Any facilities still using COVID-19 Cue tests should switch to using a different COVID-19 test.
Recommendations from the FDA
- 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 using a different FDA-authorized test if anyone tested negative on the Cue Health COVID-19 test but still has symptoms. 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.
COVID-19 rapid antigen tests still available while supplies last
Correctional facilities and homeless service providers can order rapid antigen tests from MDH to test staff and residents for COVID-19. Tests will be available while supplies last. Order tests here:https://redcap.health.state.mn.us/redcap/surveys/?s=WL9N3NLT4L
Cue Health COVID-19 telehealth test-to-treat program ended
The no-cost telehealth test-to-treat program for COVID-19 through Cue Health has ended. Patients can still access COVID-19 treatment through their clinic, the federal test-to-treat locator, pharmacy clinics, and the Minnesota public hotline. Patient assistance programs to cover the cost of medications are also available. For more information on these options, visit COVID-19 Medications.
To consult with MDH about a specific COVID-19 response challenge in your facility, please reach out to the COVID-19 Highly Impacted Settings Team at Health.R-congregate@state.mn.us. We are here to help!
|
