{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "141549",
      "product_res_number": "Z-0611-2016",
      "event_date_initiated": "2015-11-11",
      "event_date_posted": "2016-01-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-09-23",
      "res_event_number": "72570",
      "product_code": "DAP",
      "k_numbers": [
        "K110303"
      ],
      "product_description": "Siemens Acute Care DDMR TestPak\nCatalog Number: CDDMRE\nSMN: 10701511 \n in vitro diagnostic",
      "code_info": "Lot Numbers: 405131002, 405173002, 405187002, 405208002, 405229002 405278002, 405292002",
      "firm_fei_number": "3002637618",
      "recalling_firm": "Siemens Healthcare Diagnostics Inc",
      "address_1": "2 Edgewater Dr",
      "city": "Norwood",
      "state": "MA",
      "postal_code": "02062-4637",
      "additional_info_contact": "781-269-3000",
      "reason_for_recall": "Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems",
      "root_cause_description": "Labeling design",
      "action": "Siemens Healthcare  Diagnostics issued  an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on November 11, 2015 both in the United States and internationally  for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions.  Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative.  For questions regarding call 781-269-3000.",
      "product_quantity": "2647",
      "distribution_pattern": "Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.",
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        "device_name": "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2"
      }
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  ]
}