{
  "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": [
    {
      "country": "United States",
      "city": "Brea",
      "address_1": "250 S Kraemer Blvd",
      "reason_for_recall": "Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de sant¿ (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).",
      "address_2": "",
      "product_quantity": "45,278 units total (2,419 units in US)",
      "code_info": "623913, 625701, 628771, 630349, 633070 and All Future Lots",
      "center_classification_date": "20170512",
      "distribution_pattern": "Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe",
      "state": "CA",
      "product_description": "Access BR Monitor, Part No. 387620",
      "report_date": "20170524",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Beckman Coulter Inc.",
      "recall_number": "Z-2074-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77029",
      "termination_date": "20180604",
      "more_code_info": "",
      "recall_initiation_date": "20170413",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}