{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "36812",
      "product_res_number": "Z-0674-05",
      "event_date_initiated": "2004-10-26",
      "event_date_posted": "2005-04-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30924",
      "product_code": "MSV",
      "k_numbers": [
        "K982879"
      ],
      "product_description": "Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.",
      "code_info": "software version 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 Services\n800-328 Ext. 1482",
      "reason_for_recall": "Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.",
      "root_cause_description": "Other",
      "action": "Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert  specifications.",
      "product_quantity": "7",
      "distribution_pattern": "CT, MI, MT, UT & CANADA",
      "openfda": {
        "k_number": [
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          "K982879",
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          "K982391",
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        ],
        "registration_number": [
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          "9610566",
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        "fei_number": [
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        ],
        "device_name": "System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5660",
        "device_class": "2"
      }
    }
  ]
}