{
  "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 has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053.  Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.",
      "address_2": "PO BOX 6101",
      "product_quantity": "1,638",
      "code_info": "Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.",
      "center_classification_date": "20130418",
      "distribution_pattern": "Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.",
      "state": "DE",
      "product_description": "Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.",
      "report_date": "20130424",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-1151-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64596",
      "termination_date": "20140107",
      "recall_initiation_date": "20130221",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}