{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Newark",
      "state": "DE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69434",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr Ms 514",
      "address_2": "PO BOX 6101",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and internationally to: Canada.",
      "recall_number": "Z-0420-2015",
      "product_description": "Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension 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.",
      "product_quantity": "53, 046",
      "reason_for_recall": "Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP).   QC samples may exhibit a similar bias.",
      "recall_initiation_date": "20140930",
      "center_classification_date": "20141121",
      "termination_date": "20150810",
      "report_date": "20141203",
      "code_info": "Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number  K3105A, Siemens Material Number (SMN)  10470481, Lot Numbers  13294BA 13308BA  13329AA 13350AA  14006AA 14041BA  14069BB 14083BA      Siemens Dimension HB1C Flex reagent cartridge:  Catalog Number  DF105A, Siemens Material Number (SMN)  10483822, Lot Numbers  GA4266 BA4273 BA4280  BA4287 GA4301 GA4315  GC4322 GA4343 GA4350  GA4357 GA5013 GA5020",
      "more_code_info": ""
    }
  ]
}