{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "190088",
      "product_res_number": "Z-0310-2022",
      "event_date_initiated": "2021-10-18",
      "event_date_created": "2021-11-29",
      "recall_status": "Open, Classified",
      "res_event_number": "88949",
      "product_code": "KLI",
      "k_numbers": [
        "K991432"
      ],
      "product_description": "Total Thyroxine (T4) ELISA; REF EIA-1781",
      "code_info": "lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021",
      "firm_fei_number": "2245285",
      "recalling_firm": "DRG International, Inc.",
      "address_1": "841 Mountain Ave",
      "city": "Springfield",
      "state": "NJ",
      "postal_code": "07081-3437",
      "additional_info_contact": "Ina Hairston\n973-564-7555",
      "reason_for_recall": "Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 10/18/2021, DRG issued Medical Device Recall Notification letters and response forms to the End-user through confirmation of the Distributor.  All customers were notified via e-mail.  \nActions Required:\n1) Please immediately discontinue use or distribution of the affected lots. \n2) If you have further distributed the affected product lots, please identify and immediately notify those customers at once of this product recall by providing a copy of the recall notice and response form.\n3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process and notify the appropriate regulatory bodies as required.\n4) Disposal of all affected lots should be in accordance with applicable national, st ate, and local laws and regulations.\n5) Complete and return the response form.",
      "product_quantity": "314 total (270 US)",
      "distribution_pattern": "Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM",
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        "device_name": "Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1700",
        "device_class": "2"
      }
    }
  ]
}