{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Stamford",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63615",
      "recalling_firm": "Sekisui Diagnostics Llc",
      "address_1": "500 West Avenue",
      "address_2": "N/A",
      "postal_code": "06902",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.",
      "recall_number": "Z-0463-2013",
      "product_description": "Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use  for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma.  Catalog # 101201.    Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.",
      "product_quantity": "63 kits",
      "reason_for_recall": "Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0  IU/ml standard reducing  the slope of the standard curve requiring more frequent sample dilutions.",
      "recall_initiation_date": "20121024",
      "center_classification_date": "20121203",
      "termination_date": "20130108",
      "report_date": "20121212",
      "code_info": "Lot # 120827, exp 11/27/2012"
    }
  ]
}