{
  "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": "Newark",
      "address_1": "500 Gbc Dr Ms 514",
      "reason_for_recall": "Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.",
      "address_2": "PO BOX 6101",
      "product_quantity": "314 calibrators",
      "code_info": "Lots 6JD079 and 6MD042",
      "center_classification_date": "20170404",
      "distribution_pattern": "Worldwide Distribution - United States Nationwide:  Denmark  Sweden  Norway  Great Britain  Belgium  Netherlands  Spain  Israel  Switzerland  France  Portugal  Greece  Germany  Slovenia  Czech Republic  Hong Kong                    Colombia                   Korea                          Australia",
      "state": "DE",
      "product_description": "ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture    Product Usage:  Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c",
      "report_date": "20170412",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-1712-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76695",
      "termination_date": "20180509",
      "recall_initiation_date": "20170223",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}