{
  "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": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65655",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide and the countries of   Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom",
      "recall_number": "Z-1951-2013",
      "product_description": "ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915.    Product Usage:  ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.",
      "product_quantity": "718 units total (132 units in US)",
      "reason_for_recall": "Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.",
      "recall_initiation_date": "20100922",
      "center_classification_date": "20130810",
      "termination_date": "20130810",
      "report_date": "20130821",
      "code_info": "Lot No. T006042",
      "more_code_info": ""
    }
  ]
}