{
  "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
    }
  },
  "results": [
    {
      "cfres_id": "50969",
      "product_res_number": "Z-0736-2007",
      "event_date_initiated": "2007-03-16",
      "event_date_posted": "2007-04-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-06-12",
      "res_event_number": "37599",
      "product_code": "KXT",
      "k_numbers": [
        "K851032"
      ],
      "product_description": "Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.",
      "code_info": "All Reagent Lots (including Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Corp.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "800-428-2336",
      "reason_for_recall": "The lower detection limit (LDL) may be a higher value than stated in the labeling.  Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.",
      "root_cause_description": "Other",
      "action": "A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.",
      "product_quantity": "4,735",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "k_number": [
          "K972794",
          "K951391",
          "K854972",
          "K983151",
          "K153301",
          "K983323",
          "K915602",
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          "K861195",
          "K093441",
          "K943500",
          "K931123",
          "K864223",
          "K920214",
          "K884054",
          "K011302",
          "K012301",
          "K941255",
          "K925802",
          "K833791",
          "K911941",
          "K952079",
          "K033007",
          "K901547",
          "K840673",
          "K841582",
          "K011920",
          "K963835",
          "K023058",
          "K924594",
          "K931213",
          "K953718",
          "K861394",
          "K951441",
          "K790303",
          "K970881",
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          "K894521",
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          "K880823",
          "K982935",
          "K872583",
          "K861393",
          "K940267",
          "K934135",
          "K924504",
          "K946153",
          "K940569",
          "K901216",
          "K833878",
          "K882233",
          "K970883",
          "K082953",
          "K951755",
          "K896863",
          "K930162",
          "K841107",
          "K061249",
          "K932250",
          "K934168",
          "K893843",
          "K851032",
          "K870951",
          "K823199",
          "K802358",
          "K943983",
          "K980521",
          "K850458",
          "K790937",
          "K842571",
          "K812054",
          "K944506",
          "K102346",
          "K893910",
          "K932732",
          "K842655"
        ],
        "registration_number": [
          "2432235",
          "2020726",
          "2050012",
          "3010939897",
          "3002809144",
          "3006198300",
          "1219913",
          "3002637618",
          "1036362",
          "9610126",
          "2122870",
          "3003561301",
          "3002806944",
          "3004192065",
          "2517506",
          "8020888",
          "9610746",
          "3005333358",
          "2050010",
          "3004493545",
          "9610529",
          "3010825766",
          "3003795116"
        ],
        "fei_number": [
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          "3002806559",
          "2020726",
          "2050012",
          "3010939897",
          "3002809144",
          "3006198300",
          "1219913",
          "3002637618",
          "1036362",
          "2122870",
          "3003561301",
          "3002806560",
          "3002806944",
          "3004192065",
          "2517506",
          "3005333358",
          "2050010",
          "3007019572",
          "3004493545",
          "3002806557",
          "3010825766",
          "3003795116"
        ],
        "device_name": "Enzyme Immunoassay, Digoxin",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3320",
        "device_class": "2"
      }
    }
  ]
}