{
  "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": "63632",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "N/A",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the country of Canada.",
      "recall_number": "Z-0612-2013",
      "product_description": "Access Immunoassay System,  Access 2 Immunoassay System,  Synchron LXi 725 Clinical  System, UniCel DxC 600i  Synchron Access Clinical System    Part Numbers: Access \u0013 81600;  Access 2 \u0013 81600N, 386220, A69186, A25656, A12900;  Access 2 (LXi) \u0013 A15642;  Access 2 Section, DxC 600i \u0013 A25640.    The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.",
      "product_quantity": "6,858 units",
      "reason_for_recall": "It has been determined that, in some cases,  pulley drive components have broken parts or have become loose, mispositioned, or  disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or  may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the  reaction vessel.",
      "recall_initiation_date": "20121101",
      "center_classification_date": "20121222",
      "termination_date": "20131223",
      "report_date": "20130102",
      "code_info": "Part Numbers: Access \u0013 81600;  Access 2 \u0013 81600N, 386220, A69186, A25656, A12900;  Access 2 (LXi) \u0013 A15642;  Access 2 Section, DxC 600i \u0013 A25640"
    }
  ]
}