{
  "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": "155942",
      "product_res_number": "Z-0173-2018",
      "event_date_initiated": "2017-05-23",
      "event_date_created": "2017-11-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-03-30",
      "res_event_number": "77381",
      "product_code": "CHN",
      "k_numbers": [
        "K082503"
      ],
      "product_description": "Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD",
      "code_info": "Lot numbers: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B, 6CC001F (exp. date  2017-07-14); 6FC001A, 6FC001C, 6FC001E (exp. 2017-10-27); --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714),  6CC001B (008427680244436CC001B20170714),  6CC001F (008427680244436CC001F20170714),  6FC001A (008427680244436FC001A20171027),  6FC001C (008427680244436FC001C20171027),  6FC001E (008427680244436FC001E20171027),  6JC001 (008427680244436JC00120180111),  6JC001C (008427680244436JC001C20180111),  6JC001G (008427680244436JC001G20180111),  6MC001 (008427680244436MC00120180429),  6MC001C (008427680244436MC001C20180429).",
      "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": "Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L].   PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens issued an Urgent Medical Device Correction (UMDC) letter (PP-17-012.A.US, dated May 23, 2017) to US customers on May 23, 2017 and an Urgent Field Safety Notice (UFSN) to customers Outside the US in May 2017.  Customers were instructed in the letter to use re-assigned CER values for the lots indicated of PROT1 CAL and PROT1 CON L, M, and H.  In the US, the method of distribution is FEDEX and outside the US, the distribution is determined at the country level.  Customers were requested to complete Effectiveness Check questionnaire attached to the UMDC/UFSN and return to Siemens within 30 days.",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada,  France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South",
      "openfda": {
        "registration_number": [
          "3003795116",
          "3006198300",
          "9610126",
          "9610529",
          "9610806"
        ],
        "fei_number": [
          "3002806559",
          "3002806560",
          "3003795116",
          "3006198300",
          "3001644026"
        ],
        "device_name": "Immunochemical, Ceruloplasmin",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5210",
        "device_class": "2",
        "k_number": [
          "K062114",
          "K091741",
          "K063655"
        ]
      }
    }
  ]
}