{
  "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": "The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.",
      "address_2": "PO BOX 6101",
      "product_quantity": "1,697 units",
      "code_info": "Device Listing Number # D121541  Lot # 16148AA, 16190BA, 16201BA, 16228BC, 16256BA, 16277BB  16298AB, 16343BE,17005BC",
      "center_classification_date": "20170616",
      "distribution_pattern": "Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada  Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria  Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland  India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia  Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal  Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa",
      "state": "DE",
      "product_description": "Dimension Vista Estradiol (E2) Flex reagent cartridge",
      "report_date": "20170628",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-2608-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76915",
      "termination_date": "20180803",
      "more_code_info": "",
      "recall_initiation_date": "20170321",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}