{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "36869",
      "product_res_number": "Z-0634-05",
      "event_date_initiated": "2004-07-15",
      "event_date_posted": "2005-03-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30937",
      "product_code": "CIZ",
      "k_numbers": [
        "K854650"
      ],
      "product_description": "DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.  Lot # 05144.  for the quantitative determination of androstenedione levels in serum.",
      "code_info": "Catalog No. CA 1725,  Lot # 05144",
      "firm_fei_number": "2182595",
      "recalling_firm": "Diasorin Inc.",
      "address_1": "1951 Northwestern Ave S",
      "city": "Stillwater",
      "state": "MN",
      "postal_code": "55082-7536",
      "additional_info_contact": "DiaSorin Technical Service\n800-328-1482",
      "reason_for_recall": "Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.",
      "root_cause_description": "Other",
      "action": "Customers were sent a customer notification letter identifying the product and the problem and requesting a response identifying the number of replacement kits needed.",
      "product_quantity": "163 Kits (lot 05144)  95 Kits (06114B)",
      "distribution_pattern": "MN, MA, KY, Saudi Arabia, Jordan, Sweden, Germany, Spain, Belgium, Italy, Canada, Australia, Portugal, Hungary, Switzerland & Israel",
      "openfda": {
        "device_name": "Radioimmunoassay, Androstenedione",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1075",
        "device_class": "1",
        "k_number": [
          "K854673",
          "K934751",
          "K963002",
          "K844398",
          "K832452",
          "K860559",
          "K801729",
          "K854650",
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          "K954755"
        ],
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}