{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84915",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI.",
      "recall_number": "Z-1444-2020",
      "product_description": "Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer",
      "product_quantity": "684",
      "reason_for_recall": "The firm has received an increased number of complaints concerning non-reproducible elevated results (\"high flyers\") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.",
      "recall_initiation_date": "20200207",
      "center_classification_date": "20200305",
      "termination_date": "20240530",
      "report_date": "20200311",
      "code_info": "Lot 416245 ***Updated 10/5/20*** 483123   ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976"
    }
  ]
}