{
  "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": "Crumlin (North)",
      "state": "",
      "country": "Ireland",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83373",
      "recalling_firm": "Randox Laboratories Ltd.",
      "address_1": "55 Diamond Road",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide  Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,",
      "recall_number": "Z-2490-2019",
      "product_description": "This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.",
      "product_quantity": "307 kits",
      "reason_for_recall": "Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).",
      "recall_initiation_date": "20190712",
      "center_classification_date": "20190907",
      "termination_date": "20200617",
      "report_date": "20190918",
      "code_info": "Lot Numbers: 961UE onwards  GTN: 05055273200966",
      "more_code_info": ""
    }
  ]
}