{
  "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": "Sees",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80321",
      "recalling_firm": "ELITech Clinical Systems SAS",
      "address_1": "Zone Industrielle des Fourneaux",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. only. No gov. accounts. No international.",
      "recall_number": "Z-2591-2018",
      "product_description": "ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x  20 mL Calibrator Low level). Model/Catalog Number: 55117",
      "product_quantity": "N/A",
      "reason_for_recall": "ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages \"ISE OUT OF REPRODUCIBILITY\" or \"ISE SLOPE OUT OF RANGE\" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.",
      "recall_initiation_date": "20170418",
      "center_classification_date": "20180801",
      "termination_date": "20200417",
      "report_date": "20180808",
      "code_info": "Lot number    7038      , Manufacture date   03/2017,        Expiration date 02/2019"
    }
  ]
}