{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Chaska",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95473",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "1000 Lake Hazeltine Dr",
      "address_2": "N/A",
      "postal_code": "55318-1037",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.",
      "recall_number": "Z-0313-2025",
      "product_description": "The Access Cortisol assay is a paramagnetic particle, chemiluminescent  immunoassay for the quantitative determination of cortisol levels in human  serum, plasma (heparin, EDTA) and urine using the Access Immunoassay  Systems.",
      "product_quantity": "149 units",
      "reason_for_recall": "The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number.  Calibration failure would lead to delay of measurement results reporting and potential injuries.",
      "recall_initiation_date": "20240930",
      "center_classification_date": "20241106",
      "report_date": "20241113",
      "code_info": "UDI/DI 15099590231118, all lots",
      "more_code_info": ""
    }
  ]
}