{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "cfres_id": "219630",
      "product_res_number": "Z-2082-2026",
      "event_date_initiated": "2026-04-02",
      "event_date_posted": "2026-05-06",
      "recall_status": "Open, Classified",
      "res_event_number": "98739",
      "product_code": "MVO",
      "product_description": "One Step 10A in vitro diagnostic test",
      "code_info": "UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905",
      "firm_fei_number": "3005841640",
      "recalling_firm": "DFI Co., Ltd.",
      "address_1": "388-25 Gomo-Ro 388-25 gimhae korea the republic of gomo-ro",
      "city": "Jillye-Myeon",
      "additional_info_contact": "Yongae Park\n55-3461882",
      "reason_for_recall": "The devices were distributed without required FDA premarket clearance or approval.",
      "root_cause_description": "No Marketing Application",
      "action": "On April 2, 2026 Dream Future Innovation (DFI Co., Ltd.) issued a Urgent Medical Device Recall Notification to affected consignees via E. Mail. DFI ask consignees to take the following actions: \n\n4.1\tDistribution required Actions\n1)\tImmediate Discontinuation: Immediately stop the use and distribution of the Products.\n2)\tInventory Quarantine: Quarantine all remaining inventory in a safe place and attach a  NOT FOR SALE  label. \n3)\tReply to Acknowledgement: Please fill out the attached  Recall Acknowledgement Report  and return it within 10 business days of receiving this notice \n4)\tSub-distributor Notification: Immediately notify all sub-distributors or end customers receiving Products.\n\n4.2\tEnd Customer required Actions\n    1) Stop using the product immediately.\n2) Do not give or sell the product to anyone else.\n3) Follow the instructions below regarding destruction or disposal.\n4) Submit your refund / confirmation request as instructed.\n< Destruction / Disposal Instructions >\nTo prevent accidental use, please cut the unused test strip(s) in half.\nAfter cutting the strips in half, please dispose of the destroyed components in accordance with your local municipal waste regulations",
      "product_quantity": "6533 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.",
      "openfda": {
        "k_number": [
          "K992685",
          "K010655",
          "K010646",
          "K992217",
          "K991641",
          "K013778",
          "K013412",
          "K991824",
          "K982621",
          "K991465",
          "K003858",
          "K014192",
          "K010654",
          "K010653",
          "K030447",
          "K013410",
          "K013409",
          "K040327"
        ],
        "registration_number": [
          "2246703",
          "2029372",
          "1832216",
          "3005360469",
          "3026478116",
          "3026478115",
          "2031229"
        ],
        "fei_number": [
          "2246703",
          "3000719950",
          "1832216",
          "3026478116",
          "3026478115",
          "3005670738",
          "1000306617"
        ],
        "device_name": "Kit, Test, Multiple, Drugs Of Abuse, Over The Counter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}