{
  "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": "36879",
      "product_res_number": "Z-0807-05",
      "event_date_initiated": "2004-09-24",
      "event_date_posted": "2005-05-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30946",
      "product_code": "DHN",
      "k_numbers": [
        "K822397"
      ],
      "product_description": "Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.",
      "code_info": "all versions of software",
      "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": "A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed.  The graph may appear valid; however erroneous results may occur.",
      "root_cause_description": "Other",
      "action": "Customers were sent a Technical Bulletin describing the correct procedure to be used when entering data into the Poly/Titer tiration system, until the updated software is installed",
      "product_quantity": "13",
      "distribution_pattern": "OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV",
      "openfda": {
        "k_number": [
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          "K984398",
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          "K070763",
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        "registration_number": [
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          "3010127294",
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          "2029372",
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          "3026753391",
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          "1181055",
          "3007361513",
          "3003825930",
          "2918768",
          "3012348571",
          "3015376545",
          "3003268355",
          "2016706",
          "3032705"
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        "fei_number": [
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          "3010127294",
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          "2182595",
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          "2915274",
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          "2016706"
        ],
        "device_name": "Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2"
      }
    }
  ]
}