{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "140938",
      "product_res_number": "Z-0339-2016",
      "event_date_initiated": "2015-09-30",
      "event_date_posted": "2015-11-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-09-01",
      "res_event_number": "72399",
      "product_code": "JGJ",
      "k_numbers": [
        "K061655"
      ],
      "product_description": "Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.",
      "code_info": "Lot Number 15063BA",
      "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": "800-441-9250",
      "reason_for_recall": "Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "An Urgent Medical Device Recall dated September 2015 was provided to all Dimension Vista MG customers who received the affected lot to notify them of the issue, the potential risk to health, and actions to be taken by customers.\r\n1.  An Urgent Medical Device Recall was provided to all customers who received the affected lot to notify them of the following:\r\nSiemens has received customer complaints for Dimension Vista MG lot 15063BA, regarding sporadic depressed serum/plasma and QC results.\r\nDiscontinue use and discard their remaining inventory of the affected lot.\r\nReview the letter with their Medical Director.  Siemens will replace any unused inventory of the affected lot.",
      "product_quantity": "3601",
      "distribution_pattern": "Distributed US (nationwide) including DC and the states of IL, CA, GA, LA, TX, TN, FL, SC, IA, TN, DE, NJ, WA, MS, KY, NY, WI, OH, OH, MO, UT, KS, VA, AR, WV, MA, PA, AL, CO, IN, MT, NM, ME, AZ, NM, MO, and NC, and the country of Canada.",
      "openfda": {
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          "K920603",
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          "K870370",
          "K903341",
          "K853853",
          "K923411",
          "K063208",
          "K853592",
          "K800327"
        ],
        "registration_number": [
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        "fei_number": [
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          "1832216",
          "3010939897",
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        ],
        "device_name": "Photometric Method, Magnesium",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1495",
        "device_class": "1"
      }
    }
  ]
}