{
  "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": "Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources.  All lots of IRON Flex(R) reagent cartridges have the potential for this issue.  If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the mag",
      "address_2": "PO BOX 6101",
      "product_quantity": "19,310",
      "code_info": "Lot numbers 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC and 12188BD.",
      "center_classification_date": "20121203",
      "distribution_pattern": "Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to Canada, AU, NZ, JP, DE, SA, and MY",
      "state": "DE",
      "product_description": "Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085)    The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.",
      "report_date": "20121212",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-0452-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63429",
      "termination_date": "20140114",
      "recall_initiation_date": "20121008",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}