{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "149667",
      "product_res_number": "Z-0050-2017",
      "event_date_initiated": "2016-09-07",
      "event_date_posted": "2016-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-09-07",
      "res_event_number": "75208",
      "product_code": "DGC",
      "k_numbers": [
        "K010855"
      ],
      "product_description": "IgE Calibrator Series",
      "code_info": "Catalogue number  IE2492  Batch number  354213, 386994",
      "firm_fei_number": "1000361607",
      "recalling_firm": "Randox Laboratories Ltd.",
      "address_1": "55 Diamond Road",
      "city": "Crumlin",
      "state": "North",
      "country": "Ireland",
      "reason_for_recall": "According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234.\n\nTurbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm plans on contacting each consignee about the recall.",
      "product_quantity": "4",
      "distribution_pattern": "All consignees are in the US.",
      "openfda": {
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        ],
        "device_name": "Ige, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2"
      }
    }
  ]
}