{
  "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": [
    {
      "status": "Terminated",
      "city": "Marburg",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80431",
      "recalling_firm": "CSL Behring GmbH",
      "address_1": "Emil-von-Behring-Str. 76",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic - DE, IN, KS, MO & VA    Internationally -   Australia  Austria  Belgium  Canada  China  Czech Republic  Finland  France  Germany  Hungary  India  Italy  Japan  Latvia  Lithuania  Netherlands  Norway  Poland  Portugal  Saudi Arabia  Slovakia  Slovenia  South Africa  South Koria  Spain  Sweden  Switzerland  Taiwan  Turkey  United Kingdom  Uruguay",
      "recall_number": "Z-2931-2018",
      "product_description": "N Latex CDT Kit",
      "product_quantity": "6635 units",
      "reason_for_recall": "Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method.      CDT results in absolute concentrations may be influenced by patient\u0019s transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT.      As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This could result in a shift of weak positive patient samples into the reference range of 1.19 \u0013 2.47 %CDT which was derived from a study population of healthy adults. There are no control or calibrator materials that would catch this bias.",
      "recall_initiation_date": "20180531",
      "center_classification_date": "20180825",
      "termination_date": "20210212",
      "report_date": "20180905",
      "code_info": "UDI -  842768018534    Lot # 47169, Exp Date: 2018-06-15  Lot # 47596, Exp Date: 2018-11-30  Lot # 47716, Exp Date: 2018-11-30  Lot # 48084, Exp Date: 2019-03-21  Lot # 48168, Exp Date: 2019-03-21"
    }
  ]
}