Mary Wilson
Well-known member
Date Issued: May 13, 2024
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
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.
The FDA issued a Warning Letter to Cue Health on May 10, 2024, 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’s COVID-19 Tests due to this increased risk of false results.
The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
https://www.fda.gov/medical-devices...e-risk-false-results-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.
- 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.
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.
The FDA issued a Warning Letter to Cue Health on May 10, 2024, 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’s COVID-19 Tests due to this increased risk of false results.
The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
https://www.fda.gov/medical-devices...e-risk-false-results-fda-safety-communication