{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "36818",
      "product_res_number": "Z-0675-05",
      "event_date_initiated": "2004-04-12",
      "event_date_posted": "2005-04-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30928",
      "product_code": "JZO",
      "k_numbers": [
        "K952183"
      ],
      "product_description": "Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).",
      "code_info": "software version 9 thru 12",
      "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": "The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty.  This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay.  The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.",
      "root_cause_description": "Other",
      "action": "Customers were sent a notification letter directing customers to check historical data for negative control results reading greater than 0.95 but less than 1.0.  These results are invalid and patient results should not have been reported.  Customers are instructed to verify negative control manually until new software version is installed.  An effectiveness check form is requested to be returned.",
      "product_quantity": "6",
      "distribution_pattern": "CA, FL, MA, NY & TX",
      "openfda": {
        "k_number": [
          "K950217",
          "K925923",
          "K020348",
          "K020687",
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          "K052407",
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          "K083391",
          "K080159",
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          "K213517",
          "K915135",
          "K992790",
          "K952183",
          "K915428",
          "K843343",
          "K984165",
          "K950089",
          "K090760",
          "K915133",
          "K984163",
          "K012777",
          "K020349",
          "K925826",
          "K983992"
        ],
        "registration_number": [
          "9610566",
          "2432235",
          "9612316",
          "8031673",
          "2245285",
          "8023018",
          "3005529799",
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          "1036362",
          "3003834021",
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          "1181121",
          "3002806944",
          "9680746",
          "2090110",
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          "8020888",
          "8043792",
          "1528450",
          "3005333358",
          "3002800697",
          "2032839",
          "3039353646",
          "1421346",
          "3033967997"
        ],
        "fei_number": [
          "3002808269",
          "3002808328",
          "2432235",
          "2245285",
          "3002806559",
          "1000206808",
          "3005529799",
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          "3002809144",
          "1000306617",
          "3006198300",
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          "3002808039",
          "1219913",
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          "3002800697",
          "3007019572",
          "3039353646",
          "3002807876",
          "1421346",
          "3033967997"
        ],
        "device_name": "System, Test, Thyroid Autoantibody",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5870",
        "device_class": "2"
      }
    }
  ]
}