{
  "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": "36851",
      "product_res_number": "Z-0676-05",
      "event_date_initiated": "2004-06-30",
      "event_date_posted": "2005-04-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30934",
      "product_code": "DHN",
      "k_numbers": [
        "K822397"
      ],
      "product_description": "PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100  which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies.  REF: 1624, 1662, 1660, 6624, 1604",
      "code_info": "polyTiter software version 2.8",
      "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": "The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.",
      "root_cause_description": "Other",
      "action": "All customers were notified of the problem via phone and letter.   Verbal instructions were given of how to change the  Calibrator 2 titer to the correct one.  A letter instructs customer to return software disc to DiaSorin, remove version 2.8 from the computer and install version 2.8.1.",
      "product_quantity": "14",
      "distribution_pattern": "AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH,  TX,  & VA",
      "openfda": {
        "k_number": [
          "K870458",
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          "K150155",
          "K760206",
          "K803276",
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          "K791493",
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          "K871395",
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          "K024225",
          "K944096",
          "K760153",
          "K834241",
          "K012163",
          "K912292",
          "K811714",
          "K760681",
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          "K772219",
          "K771376",
          "K832383",
          "K024227",
          "K024229",
          "K854314",
          "K860183",
          "K990915",
          "K862821",
          "K863717",
          "K172745",
          "K841776",
          "K013213",
          "K201956",
          "K822397",
          "K810301",
          "K780161",
          "K810081",
          "K141827",
          "K897025",
          "K760209",
          "K843225",
          "K153117",
          "K791995",
          "K812314",
          "K802299",
          "K024224",
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          "K970198",
          "K874873",
          "K844678",
          "K984399",
          "K972145",
          "K792184",
          "K833119",
          "K842183",
          "K771064",
          "K843347",
          "K790280",
          "K022800",
          "K024231",
          "K024221",
          "K070763",
          "K813592",
          "K160265",
          "K842991"
        ],
        "registration_number": [
          "2914537",
          "3010127294",
          "2026994",
          "2182595",
          "2915274",
          "3004973408",
          "2242436",
          "2029372",
          "3032523590",
          "3026753391",
          "1419968",
          "3007118747",
          "1181055",
          "3007361513",
          "3003825930",
          "2918768",
          "3012348571",
          "3015376545",
          "3003268355",
          "2016706",
          "3032705"
        ],
        "fei_number": [
          "2914537",
          "3010127294",
          "2026994",
          "2182595",
          "1000306617",
          "2915274",
          "3004973408",
          "2242436",
          "3002701146",
          "3032523590",
          "3026753391",
          "1419968",
          "3007118747",
          "1181055",
          "3007361513",
          "3003825930",
          "2918768",
          "3012348571",
          "3015376545",
          "3003268355",
          "2016706"
        ],
        "device_name": "Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2"
      }
    }
  ]
}