{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bridgend",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74366",
      "recalling_firm": "ORTHO-CLINICAL DIAGNOSTICS",
      "address_1": "FELINDRE MEADOWS",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda",
      "recall_number": "Z-2302-2016",
      "product_description": "VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code  874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics,    For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.",
      "product_quantity": "US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda",
      "reason_for_recall": "Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.",
      "recall_initiation_date": "20160602",
      "center_classification_date": "20160729",
      "termination_date": "20180608",
      "report_date": "20160810",
      "code_info": "Lot Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998",
      "more_code_info": ""
    }
  ]
}