{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130331",
      "product_res_number": "Z-0148-2015",
      "event_date_initiated": "2014-09-24",
      "event_date_posted": "2014-10-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-08-17",
      "res_event_number": "69372",
      "product_code": "DIP",
      "k_numbers": [
        "K911056"
      ],
      "product_description": "siemens Dimension Phenytoin Flex Reagent Cartridge\n\nThe PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.",
      "code_info": "lot FA5154, exp. 2015-06-03",
      "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": "Customer Support\n800-441-9250",
      "reason_for_recall": "Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens sent an Urgent Medical Device Recall Notification dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.  \n\nCustomers were instructed as follows: \n\n\" Discontinue use and discard any remaining inventory of PTN lot FA5154, and complete the attached form indicating your replacement product needs in the attached Field Correction Effectiveness Form.  \n\" Siemens will replace any unused inventory of the affected lot at no charge.\n\nWe apologize for the inconvenience this situation may have cause. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800) 441-9250, or your local Siemens technical support representative.",
      "product_quantity": "1733",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay",
      "openfda": {
        "k_number": [
          "K832033",
          "K904815",
          "K945725",
          "K855026",
          "K913429",
          "K842092",
          "K874856",
          "K905689",
          "K000006",
          "K963840",
          "K780218",
          "K863403",
          "K911056",
          "K771233",
          "K902952",
          "K864554",
          "K811745",
          "K844991",
          "K843209",
          "K943980",
          "K834406",
          "K862349",
          "K860048",
          "K080696",
          "K030428",
          "K850712",
          "K915755",
          "K011347",
          "K860286",
          "K901080",
          "K993026",
          "K896074",
          "K842161",
          "K864925",
          "K932686",
          "K063145",
          "K832419",
          "K011393",
          "K833806",
          "K973414",
          "K941142",
          "K944085",
          "K870953",
          "K772179"
        ],
        "registration_number": [
          "2432235",
          "1319809",
          "1319808",
          "2050012",
          "3010939897",
          "3002642396",
          "3002809144",
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        ],
        "fei_number": [
          "2432235",
          "3002806559",
          "2050012",
          "3010939897",
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          "3006198300",
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          "1000305841",
          "1000305840",
          "3000308930",
          "3005333358",
          "2050010",
          "3012963943",
          "3004493545",
          "3010825766",
          "3003795116"
        ],
        "device_name": "Enzyme Immunoassay, Diphenylhydantoin",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3350",
        "device_class": "2"
      }
    }
  ]
}