{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "156195",
      "product_res_number": "Z-0190-2018",
      "event_date_initiated": "2017-06-05",
      "event_date_created": "2017-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-04-07",
      "res_event_number": "77515",
      "product_code": "CHN",
      "k_numbers": [
        "K012470"
      ],
      "product_description": "SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073",
      "code_info": "Lot Numbers(UDI): 083611A (00842768007590083611A20170711),   083611B (00842768007590083611B20170711),  083611C (00842768007590083611C20170711),  083611D (00842768007590083611D20170711), exp. date 2017-07-11;  083612 (0084276800759008361220171014),  083612A (00842768007590083612A20171014), 083612B (00842768007590083612B20171014), exp. date 2017-10-14;  083614A (00842768007590083614A20180127),  083614B (00842768007590083614B20180127), 083614C (00842768007590083614C20180127), exp. date 2018-01-27; 083615 (0084276800759008361520180411),  083615A (00842768007590083615A20180411),  083615B (00842768007590083615B20180411),  083615C (00842768007590083615C20180411), exp. date 2018-04-11;   083616B (00842768007590083616B20180730),  083616C (00842768007590083616C20180730),  083616D (00842768007590083616D20180730), exp. date 2018-07-30.",
      "firm_fei_number": "3003098680",
      "recalling_firm": "CSL Behring GmbH",
      "address_1": "Emil-von-Behring-Str. 76 76 emil-von-behring-str.",
      "city": "Marburg",
      "country": "Germany",
      "reason_for_recall": "Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL.  N/T Protein Controls SL for Ceruloplasmin are similarly biased. --- The affected standards and controls for the affected lots were incorrectly value assigned, which led to a lower result compared to correctly assigned standards.\nNote: N Antiserum to Human Ceruloplasmin (REF OUIE) works as intended. --- Siemens investigation indicated that N Protein Standard SL and corresponding N/T Protein Control SL (Levels Low, Mid and High) are inaccurately assigned for Ceruloplasmin.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "URGENT MEDICAL DEVICE CORRECTION Letter (PP17-011.a.US, dated May 30, 2017) was sent to US consignees via FedEx on 6/5/2017.  URGENT FIELD CORRECTIVE ACTION Letter was e-mailed to customers Outside the US.  Customers are instructed to use the re-assigned Ceruloplasmin values for the lots indicated in the letter.",
      "distribution_pattern": "Worldwide including the countries of United States, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Great Britain, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, japan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea (S), Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, South Africa, Switzerland, Syria, Taiwan, Thailand, Trinidad-Tobago, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Vatican, Venezuela,",
      "openfda": {
        "registration_number": [
          "3006198300",
          "9610529",
          "9610126",
          "3003795116",
          "9610806"
        ],
        "fei_number": [
          "3006198300",
          "3001644026",
          "3002806559",
          "3002806560",
          "3003795116"
        ],
        "device_name": "Immunochemical, Ceruloplasmin",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5210",
        "device_class": "2",
        "k_number": [
          "K062114",
          "K091741",
          "K063655"
        ]
      }
    }
  ]
}