{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79505",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "address_2": "N/A",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Canada, Mexico, and Thailand",
      "recall_number": "Z-1671-2018",
      "product_description": "Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge",
      "product_quantity": "N/A",
      "reason_for_recall": "Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy  Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.",
      "recall_initiation_date": "20180102",
      "center_classification_date": "20180504",
      "termination_date": "20230210",
      "report_date": "20180516",
      "code_info": "CTNI, immunoassay method, troponin subunit, K6421, SMN# 10445098    Lot codes:  16336BA  16347BD  16363BC  17032AD  17045BC  17054BD  17074BC  17093BD  17121BA  17145BE  17180BB  17193BD  17201BB  17223BA  17264BC"
    }
  ]
}