{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 727
    }
  },
  "results": [
    {
      "cfres_id": "117107",
      "product_res_number": "Z-0017-2014",
      "event_date_initiated": "2012-12-19",
      "event_date_posted": "2013-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-08-27",
      "res_event_number": "64808",
      "product_code": "JGQ",
      "product_description": "Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB\n\nThe Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.",
      "code_info": "Lot No. 11349BB",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr Ms 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "Siemens Customer Service\n800-441-9250",
      "reason_for_recall": "Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.",
      "root_cause_description": "Process control",
      "action": "The firn, Siemens, sent an \"Urgent Medical Device Correction\" letter (dated December 2012) was provided to all Dimension Vista (R) UCFP customers who have received UCFP lot 11349BB. The letter described the product, problem and actions to be taken.  The customers are instructed to discontinue use and discard any remaining inventory of Dimension Vista UCFP lot 11349BB; provide instructions for product replacement; and complete and return the attacted REQUEST FOR REPLACEMENT FORM via fax to (302) 631-8467.  Siemens will replace any un-used inventory of this lot, at no charge.\n\nIf you have any questions, please contact your Siemens Technical Solutions Center. your local Siemens Technical Support Representative or 800-441-9250.",
      "product_quantity": "3395",
      "distribution_pattern": "Worldwide distribution: US (nationwide) including sates of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, ID, KY, KS, LA, MA, MD, MI, MN, MO, MS, MT, PA, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and PR; and country of: UK.",
      "openfda": {
        "k_number": [
          "K842134",
          "K913615",
          "K925794",
          "K903914",
          "K072638",
          "K863478",
          "K780110",
          "K071239",
          "K981295",
          "K131051",
          "K981682",
          "K822231",
          "K901083"
        ],
        "registration_number": [
          "3003741796",
          "3005333358",
          "1181121",
          "3003795116",
          "3016438761",
          "3006198300",
          "9610126",
          "9610529"
        ],
        "fei_number": [
          "3003741796",
          "3005333358",
          "3002806559",
          "3002806560",
          "1181121",
          "3003795116",
          "3016438761",
          "3006198300"
        ],
        "device_name": "Turbidimetric, Total Protein",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1635",
        "device_class": "2"
      }
    }
  ]
}