{
  "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": "36846",
      "product_res_number": "Z-0704-05",
      "event_date_initiated": "2004-05-25",
      "event_date_posted": "2005-04-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30932",
      "product_code": "CIZ",
      "k_numbers": [
        "K854650"
      ],
      "product_description": "DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum.  Catalog No. CA-1725.  Lot # 04164.  DiaSorin Stillwater, Minnesota  55082-0285, U.S.A.",
      "code_info": "catalog # CA 1725, lot # 04164",
      "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 Services\n800-328-1482",
      "reason_for_recall": "Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution.  The assay validation criteria failed when the gelatinous standards were used.",
      "root_cause_description": "Other",
      "action": "Customers were sent notification letters informing them of the product and problem and recommended the destruction of any remaining inventory.  Letter also requested the completion and return of the lower portion of  the letter.",
      "product_quantity": "70 kits",
      "distribution_pattern": "Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, 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",
          "K842960",
          "K954755"
        ],
        "registration_number": [
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}