{
  "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": "Newark",
      "address_1": "500 Gbc Dr Ms 514",
      "reason_for_recall": "Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator.  Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.",
      "address_2": "PO BOX 6101",
      "product_quantity": "13,147 units",
      "code_info": "Lot Number:  4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061",
      "center_classification_date": "20170216",
      "distribution_pattern": "Distributed throughout the United States",
      "state": "DE",
      "product_description": "The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System.  For prescription use only.",
      "report_date": "20170222",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-1216-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76293",
      "termination_date": "20180202",
      "more_code_info": "",
      "recall_initiation_date": "20160505",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}