{
  "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 Drive, Mailstop 514",
      "reason_for_recall": "Firm has received complaints from customers of \"Abnormal Reaction\" errors occurring on calibrations, QC and patient samples.  The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.",
      "address_2": "PO BOX 6101",
      "product_quantity": "959 cartons",
      "code_info": "Lots 12135AE and 12171BB",
      "center_classification_date": "20121120",
      "distribution_pattern": "USA (nationwide) including the states of  AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.",
      "state": "DE",
      "product_description": "Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071)    The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.",
      "report_date": "20121128",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-0408-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62835",
      "termination_date": "20140108",
      "recall_initiation_date": "20120809",
      "postal_code": "19714-6101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}