{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "36809",
      "product_res_number": "Z-0672-05",
      "event_date_initiated": "2004-04-20",
      "event_date_posted": "2005-04-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30920",
      "product_code": "LLL",
      "k_numbers": [
        "K944505"
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      "product_description": "Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.",
      "code_info": "software versions 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 Services\n800-328-1482",
      "reason_for_recall": "An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.",
      "root_cause_description": "Other",
      "action": "Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications.   Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0.   A response form is asked to be faxed back to DiaSorin.",
      "product_quantity": "29",
      "distribution_pattern": "CT, FL, NY, WA, TX, AR, TN, CANADA",
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        "device_name": "Extractable Antinuclear Antibody, Antigen And Control",
        "medical_specialty_description": "Immunology",
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}