{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130682",
      "product_res_number": "Z-0128-2015",
      "event_date_initiated": "2012-10-09",
      "event_date_posted": "2014-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-06-18",
      "res_event_number": "69449",
      "product_code": "DBF",
      "k_numbers": [
        "K110736"
      ],
      "product_description": "ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only.  (In-Vitro Diagnostic)\r\n\r\nCatalog Number: \r\n03439230 (2 pack)",
      "code_info": "Lot numbers:  82052A22    Exp Date 01/19/2013 82335A22  82909A22  85268A22  86701B22  88921B22  89956B22 90925B22 91336B22 95231A23   Exp. Date: 01/16/2013 95553A23",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "Same\n508-668-5000",
      "reason_for_recall": "Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens issued an Urgent Field Safety Notice via e-mail to all US customers affected on October 9, 2012. This notice informs the customer of the Field Correction and the actions that need to be taken. The Urgent Field Safety Notice instructs customers that upon receipt of Calibrator C Lots ending in 25 and higher (Cal C lots CC25LA and higher and Cal C lots CC25HA and higher), discontinue use of the Calibrator C lots ending in 22 and 23 with the ADVIA Centaur Ferritin assay when used on the ADVIA Centaur CP system. A confirmation fax-back form is included to ensure that all customers worldwide\r\nhave been notified and have complied with the mandatory action. \r\n\r\nFurther questions please call (508) 668-5000",
      "product_quantity": "8263 kits",
      "distribution_pattern": "Worldwide Distribution -  Nationwide Distribution and the countries of  Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.",
      "openfda": {
        "k_number": [
          "K862960",
          "K014293",
          "K874572",
          "K931576",
          "K905770",
          "K920952",
          "K952286",
          "K970612",
          "K030124",
          "K770702",
          "K800299",
          "K870107",
          "K904822",
          "K790490",
          "K973202",
          "K100538",
          "K811880",
          "K780490",
          "K801580",
          "K053211",
          "K983759",
          "K901075",
          "K812901",
          "K191562",
          "K935528",
          "K800657",
          "K791860",
          "K992517",
          "K963170",
          "K984186",
          "K801676",
          "K870570",
          "K812597",
          "K862014",
          "K062746",
          "K924858",
          "K863345",
          "K892362",
          "K811808",
          "K133083",
          "K895872",
          "K193650",
          "K811804",
          "K982714",
          "K823871",
          "K871489",
          "K874031",
          "K040879",
          "K052617",
          "K812786",
          "K973331",
          "K830580",
          "K950707",
          "K830591",
          "K873573",
          "K935847",
          "K792442",
          "K823275",
          "K121232",
          "K812056",
          "K884683",
          "K841925",
          "K911175",
          "K992157",
          "K050944",
          "K883746",
          "K993273",
          "K920046",
          "K951993",
          "K983340",
          "K874203",
          "K896585",
          "K092505",
          "K792449",
          "K000662",
          "K885074",
          "K171642",
          "K801989",
          "K860137",
          "K790447",
          "K864437",
          "K822472",
          "K110736",
          "K844158",
          "K031650",
          "K974505",
          "K863487"
        ],
        "registration_number": [
          "9610240",
          "3006677029",
          "3003795116",
          "1832216",
          "1827821",
          "3009518015",
          "9612316",
          "9610529",
          "2029372",
          "3005529799",
          "3002809144",
          "2432235",
          "3005360469",
          "3005094123",
          "2050012",
          "9610126",
          "3022178699",
          "2050010",
          "2247288",
          "2084025",
          "9610806",
          "3007111389",
          "1219913",
          "8031673",
          "1319681",
          "9610746",
          "8020888",
          "3005333358",
          "3003871639",
          "2032839",
          "9680746",
          "3004493545",
          "2032682",
          "3015969360",
          "3004434309",
          "3000148879",
          "2517506",
          "3005655287",
          "3019906",
          "3006198300",
          "3005984081"
        ],
        "fei_number": [
          "3002806557",
          "3006677029",
          "3003795116",
          "1832216",
          "1827821",
          "3002808328",
          "1000122044",
          "3009518015",
          "2967",
          "3007019572",
          "3005529799",
          "3002809144",
          "2432235",
          "3004185580",
          "3005094123",
          "3002808212",
          "2050012",
          "3022178699",
          "2050010",
          "1000206808",
          "2084025",
          "3007111389",
          "1219913",
          "3003952975",
          "3005333358",
          "3003871639",
          "3002806560",
          "3004493545",
          "3005670738",
          "3015969360",
          "3004434309",
          "1000136573",
          "3000148879",
          "2517506",
          "3005655287",
          "3019906",
          "3001644026",
          "3006198300",
          "3002806559",
          "1000306617",
          "3005984081"
        ],
        "device_name": "Ferritin, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5340",
        "device_class": "2"
      }
    }
  ]
}