BEUDAMED
    FDA Recall Open, Classified

    Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

    Recall: Z-0091-2025 · Initiated May 24, 2024

    Recall

    Recall Number
    Z-0091-2025
    Event Number
    95392
    Firm
    CUE HEALTH INC
    FEI Number
    3016758165
    Product Code
    QWB
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 24, 2024
    Posted
    October 15, 2024
    Address
    4980 Carroll Canyon Rd, Ste 100, San Diego, CA, 92121-1736

    Description

    Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

    Reason

    Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.

    Action

    On 05/13/2024, FDA issued a Field Safety Notice informing/warning the public to not use Cue Health's COVID-19 Tests due to an increased risk of false results. The FDA issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus. 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. FDA Actions 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.

    Distribution

    U.S. Nationwide distribution.

    Quantity

    56 Lots (248,109 total kits)