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<\/figure>\n<\/div>\n\n\nRecommendations for Home Test Users and Caregivers<\/h2>\n\n\n\n\n- 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. \u00a0<\/li>\n\n\n\n
- Talk to your healthcare 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.<\/li>\n\n\n\n
- 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.\u00a0<\/li>\n\n\n\n
- 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\u00a0Reporting Problems with Your Test<\/a>.<\/li>\n<\/ul>\n\n\n\n
Recommendations for Health Care Providers <\/h2>\n\n\n\n\n- 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.\u00a0<\/li>\n\n\n\n
- 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.<\/li>\n\n\n\n
- Report any problems you experience with the Cue Health COVID-19 Test to the FDA, including suspected false results. See\u00a0Reporting Problems with Your Test<\/a>.<\/li>\n<\/ul>\n\n\n\n
FDA Actions<\/h2>\n\n\n\n
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. The Cue Health COVID-19 Test received initial EUA authorization on June 10, 2020. It is for use in point-of-care settings. The Cue Health COVID-19 Test for Home and Over-the-Counter Use received initial EUA authorization on March 5, 2021, and is authorized for use at home.<\/p>\n\n\n\n
The FDA issued a Warning Letter to Cue Health on May 10, 2024<\/a>, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus. The FDA is warning home test users, caregivers, and health care providers not to use Cue Health\u2019s COVID-19 Tests due to this increased risk of false results.<\/p>\n\n\n\nThe FDA will keep the public informed if significant new information becomes available. <\/p>\n\n\n\n
Reporting Problems with Your Device<\/h2>\n\n\n\n
If you think you have a problem with your device, the FDA encourages you to\u00a0report the problem through the MedWatch Voluntary Reporting Form<\/a>.<\/p>\n\n\n\nHealthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.<\/p>\n\n\n\n
Questions?<\/h2>\n\n\n\n
Recommendations for Health Care Providers <\/h2>\n\n\n\n\n- 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.\u00a0<\/li>\n\n\n\n
- 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.<\/li>\n\n\n\n
- Report any problems you experience with the Cue Health COVID-19 Test to the FDA, including suspected false results. See\u00a0Reporting Problems with Your Test<\/a>.<\/li>\n<\/ul>\n\n\n\n
FDA Actions<\/h2>\n\n\n\n
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. The Cue Health COVID-19 Test received initial EUA authorization on June 10, 2020. It is for use in point-of-care settings. The Cue Health COVID-19 Test for Home and Over-the-Counter Use received initial EUA authorization on March 5, 2021, and is authorized for use at home.<\/p>\n\n\n\n
The FDA issued a Warning Letter to Cue Health on May 10, 2024<\/a>, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus. The FDA is warning home test users, caregivers, and health care providers not to use Cue Health\u2019s COVID-19 Tests due to this increased risk of false results.<\/p>\n\n\n\nThe FDA will keep the public informed if significant new information becomes available. <\/p>\n\n\n\n
Reporting Problems with Your Device<\/h2>\n\n\n\n
If you think you have a problem with your device, the FDA encourages you to\u00a0report the problem through the MedWatch Voluntary Reporting Form<\/a>.<\/p>\n\n\n\nHealthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.<\/p>\n\n\n\n
Questions?<\/h2>\n\n\n\n
FDA Actions<\/h2>\n\n\n\n
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. The Cue Health COVID-19 Test received initial EUA authorization on June 10, 2020. It is for use in point-of-care settings. The Cue Health COVID-19 Test for Home and Over-the-Counter Use received initial EUA authorization on March 5, 2021, and is authorized for use at home.<\/p>\n\n\n\n
The FDA issued a Warning Letter to Cue Health on May 10, 2024<\/a>, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus. The FDA is warning home test users, caregivers, and health care providers not to use Cue Health\u2019s COVID-19 Tests due to this increased risk of false results.<\/p>\n\n\n\n The FDA will keep the public informed if significant new information becomes available. <\/p>\n\n\n\n If you think you have a problem with your device, the FDA encourages you to\u00a0report the problem through the MedWatch Voluntary Reporting Form<\/a>.<\/p>\n\n\n\n Healthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.<\/p>\n\n\n\nReporting Problems with Your Device<\/h2>\n\n\n\n
Questions?<\/h2>\n\n\n\n