{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210120",
      "product_res_number": "Z-0091-2025",
      "event_date_initiated": "2024-05-24",
      "event_date_posted": "2024-10-15",
      "recall_status": "Open, Classified",
      "res_event_number": "95392",
      "product_code": "QWB",
      "product_description": "Cue Health COVID-19 Test Cartridge  REF 2900005\n\nCue COVID-19 Test\nCue COVID-19 Test for Home and Over The Counter (OTC)",
      "code_info": "Product code: 2900005\nUDI code: N/A\nLot Numbers:\n30757C\n30761G\n30760C\n30884G\n30885G\n30762G\n30886G\n30879C\n30882C\n30918C\n30889G\n30926G\n30923C\n31032G\n30924C\n31040C\n31041C\n31033G\n31042C\n31043C\n31044C\n31036G\n31045C\n31046C\n31037G\n31158C\n31162C\n31161C\n31165B\n31163E\n31166B\n31038B\n31374B\n31373E\n31400B\n31465E\n31464B\n31403B\n31408E\n31404B\n31476B\n31410E\n31477B\n31478B\n31540B\n31541B\n31542B\n31543B\n31544B\n31545B\n31546B\n31479B\n31480B\n31537L\n31739L",
      "firm_fei_number": "3016758165",
      "recalling_firm": "CUE HEALTH INC",
      "address_1": "4980 Carroll Canyon Rd Ste 100 4980 Carroll Canyon Rd",
      "address_2": "Ste 100",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-1736",
      "additional_info_contact": "Chanda Owens\n408-518-2578",
      "reason_for_recall": "Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.",
      "root_cause_description": "No Marketing Application",
      "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.\n\nRecommendations for Health Care Providers \nDo not use any Cue Health COVID-19 Tests that you may still have. Dispose of the entire test cartridge in your general waste disposal. \nConsider 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.\nReport any problems you experience with the Cue Health COVID-19 Test to the FDA, including suspected false results. See Reporting Problems with Your Test.\n\nFDA Actions\nThe 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.\n\nThe 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.\n\nThe FDA will keep the public informed if significant new information becomes available.",
      "product_quantity": "56 Lots (248,109 total kits)",
      "distribution_pattern": "U.S. Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K253453",
          "DEN220028",
          "K232643"
        ],
        "device_name": "Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3984",
        "device_class": "2",
        "registration_number": [
          "3034617817"
        ],
        "fei_number": [
          "3034617817"
        ]
      }
    }
  ]
}