{
  "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": [
    {
      "country": "United States",
      "city": "Brea",
      "address_1": "250 S Kraemer Blvd",
      "reason_for_recall": "Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.",
      "address_2": "",
      "product_quantity": "3,158 units total (1,957 units in US)",
      "code_info": "M609458",
      "center_classification_date": "20170522",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.",
      "state": "CA",
      "product_description": "Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL  MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine",
      "report_date": "20170531",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Beckman Coulter Inc.",
      "recall_number": "Z-2124-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77138",
      "termination_date": "20171230",
      "more_code_info": "",
      "recall_initiation_date": "20170424",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}