{
  "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
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  },
  "results": [
    {
      "cfres_id": "114533",
      "product_res_number": "Z-0512-2013",
      "event_date_initiated": "2012-11-14",
      "event_date_posted": "2012-12-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-09-25",
      "res_event_number": "63682",
      "product_code": "KLS",
      "k_numbers": [
        "K982680"
      ],
      "product_description": "Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02)\n250 Test            08838753\n50 Test            03009619\n\nIntended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.",
      "code_info": "All lot codes",
      "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": "508-668-5000",
      "reason_for_recall": "Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.",
      "root_cause_description": "Device Design",
      "action": "Siemens Healthcare issued An Urgent Medical Device Correction Notice (for US customers) and an Urgent Field Safety Notice (for customers outside the US) dated November 5, 2012, to all affected customers.  These notices inform customers who used the ADVIA Centaur BNP, BR, CA 19-9, Digitoxin, Folate, and Theophylline 2 assays to reduce their instrument operating temperature\nrange to 20 -25 degrees C and for the DHEAS assay to reduce the\ninstrument operating temperature range to 18 -26 degrees C when these\nassays are being used. These notices also direct customers to review the\ncontents of the correction notice with their Laboratory Director or Medical\nDirector. A confirmation fax-back form was included to ensure that all\ncustomers worldwide have been notified and have complied with the\nmandatory action.\nCustomers with questions were instructed to contact their Siemens Technical Solutions Center or their local technical support representative.\nFor questions regarding this recall call 508-668-5000.",
      "product_quantity": "50 test=2397 and 250 test= 594",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to the following countries: \nArgentina\nAustralia\nAustria\nAzerbaijan\nBelgium\nBosnia Herzeg.\nBrazil\nCanada\nChile\nCOLOMBIA\nCroatia\nCzech Republic\nDenmark\nEgypt\nEstonia\nFinland\nFrance\nGermany\nGreece\nHong Kong\nHungary\nIceland\nIndia\nIndonesia\nIran\nIreland\nItaly\nJapan\nKazakhstan\nLatvia\nLithuania\nMalaysia\nMexico\nNetherlands\nNew Caledonia\nNorway\nOman\nP.R. China\nPhilippines\nPoland\nPortugal\nQatar\nRep. of Yemen\nRepublic Korea\nReunion\nRomania\nRussian Fed.\nSaudi Arabia\nSerbia\nSlovakia\nSlovenia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTaiwan\nThailand\nTurkey\nU.A.E.\nUnited Kingdom\nUruguay\nVietnam",
      "openfda": {
        "k_number": [
          "K801476",
          "K862955",
          "K862350",
          "K864041",
          "K832965",
          "K812003",
          "K854183",
          "K810578",
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          "K926245",
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          "K870952",
          "K855227",
          "K910697",
          "K896927",
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          "K952596",
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          "K841656",
          "K821544",
          "K011771",
          "K943979",
          "K973583",
          "K831934",
          "K902243",
          "K013272",
          "K870736",
          "K844642",
          "K042407",
          "K844170",
          "K935373",
          "K901510",
          "K900009",
          "K861367",
          "K853372",
          "K831272",
          "K933258",
          "K913123",
          "K972495",
          "K884358",
          "K042520",
          "K885253",
          "K803094",
          "K834244",
          "K790256",
          "K020740",
          "K821154",
          "K772017",
          "K881257",
          "K832825",
          "K011166",
          "K932685",
          "K954569",
          "K885044",
          "K832034",
          "K911060",
          "K853872",
          "K833683",
          "K873596",
          "K851741",
          "K850856",
          "K852573",
          "K833989",
          "K853834",
          "K801642",
          "K900373"
        ],
        "registration_number": [
          "2432235",
          "1319809",
          "1319808",
          "2050012",
          "3010939897",
          "3002642396",
          "3006198300",
          "1036362",
          "9610126",
          "3003561301",
          "1181121",
          "2250051",
          "3002806944",
          "2517506",
          "1181055",
          "3000308930",
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          "3005333358",
          "2050010",
          "3012963943",
          "3004493545",
          "9610529",
          "3010825766",
          "3003795116"
        ],
        "fei_number": [
          "2432235",
          "3002806559",
          "2050012",
          "3010939897",
          "3002642396",
          "3006198300",
          "1036362",
          "3003561301",
          "3002806560",
          "1181121",
          "2250051",
          "3002806944",
          "1000136573",
          "2517506",
          "1181055",
          "1000305841",
          "1000305840",
          "3000308930",
          "3005333358",
          "2050010",
          "3012963943",
          "3004493545",
          "3010825766",
          "3003795116"
        ],
        "device_name": "Enzyme Immunoassay, Theophylline",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3880",
        "device_class": "2"
      }
    }
  ]
}