{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Morrisville",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80554",
      "recalling_firm": "Tecan US, Inc.",
      "address_1": "9401 Globe Center Dr Ste 140",
      "address_2": "N/A",
      "postal_code": "27560-6211",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC,  and UT; and countries of: Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.",
      "recall_number": "Z-2923-2018",
      "product_description": "Cortisol Saliva Luminescence Immunoassay     The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.",
      "product_quantity": "870 (USA) 180 (OUS)",
      "reason_for_recall": "Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.",
      "recall_initiation_date": "20180112",
      "center_classification_date": "20180824",
      "termination_date": "20200602",
      "report_date": "20180905",
      "code_info": "In USA  RE62119 Lot # LCL129 exp. date: 2017-11-30,   RE62119 Lot # LCL133 exp. date: 2019-03-31, and   RE62111 Lot # LCL130 exp. date: 2018-03-31.  OUS    Lot 131, Lot 132"
    }
  ]
}