{
  "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": "Positive bias on the lots listed compared to alternate methods and a higher frequency of \"Above Assay Range\" flags with the lots listed.",
      "address_2": "PO BOX 6101",
      "product_quantity": "11006 Total",
      "code_info": "Catalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:12107AA, exp. 3/16/13; 12128AA, exp. 4/6/13; 12150AA, exp. 4/28/13; 12191AA, exp. 6/8/13; 12212AA, exp. 6/29/13; 12226AA, exp. 7/13/13; 12248AA, exp. 8/4/13; 12261AA, exp. 8/17/13; 12282AA, exp. 9/7/13; 12303AA, exp. 9/28/13.",
      "center_classification_date": "20140103",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.",
      "state": "DE",
      "product_description": "HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems.    Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.",
      "report_date": "20140115",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-0626-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65409",
      "termination_date": "20140212",
      "more_code_info": "",
      "recall_initiation_date": "20130422",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}