{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "197413",
      "product_res_number": "Z-0879-2023",
      "event_date_initiated": "2022-12-08",
      "event_date_posted": "2023-01-04",
      "recall_status": "Open, Classified",
      "res_event_number": "91300",
      "product_code": "QKP",
      "product_description": "Detect Covid-19 Test\nProduct/Model Number: 21205",
      "code_info": "HY263, HY264, and HB264\n\nExpiration 01JAN2023",
      "firm_fei_number": "3018103650",
      "recalling_firm": "Detect Headquarters",
      "address_1": "351 New Whitfield St",
      "city": "Guilford",
      "state": "CT",
      "postal_code": "06437-3400",
      "additional_info_contact": "Customer Support\n855-322-3692",
      "reason_for_recall": "There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.",
      "root_cause_description": "Component design/selection",
      "action": "On December 8, 2022, the firm notified affected enterprise/wholesale customers through email with subject line \"URGENT: Voluntary Recall of Three Lots of Detect Covid-19 Tests\". Direct customers were notified on December 12, 2022.\n\nCustomers were instructed to locate unused tests from the affected lots and dispose of them. Customers may receive a refund for the recalled tests once they complete an acknowledgement form and return it to Detect.",
      "product_quantity": "10142 (US); 960 OUS",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Hong Kong.",
      "openfda": {
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        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}