{
  "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": [
    {
      "country": "United States",
      "city": "Stamford",
      "address_1": "500 West Avenue",
      "reason_for_recall": "SPECTROLYSE PAI-1 activity assay  producing lower than expected absorbance values with \"0\" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.",
      "address_2": "",
      "product_quantity": "699 kits",
      "code_info": "Lot Numbers: 120425 and 120601",
      "center_classification_date": "20120920",
      "distribution_pattern": "Nationwide distribution: USA including states of: FL, IN, IL, and WA.",
      "state": "CT",
      "product_description": "Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma.   Catalog Number: 101201    For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Sekisui Diagnostics Llc",
      "recall_number": "Z-2431-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63016",
      "termination_date": "20160725",
      "more_code_info": "",
      "recall_initiation_date": "20120828",
      "postal_code": "06902",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}