{
  "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": "71755",
      "product_res_number": "Z-0297-2009",
      "event_date_initiated": "2008-05-22",
      "event_date_posted": "2008-11-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-09-09",
      "res_event_number": "48628",
      "product_code": "KXT",
      "k_numbers": [
        "K953718"
      ],
      "product_description": "AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02)\n\nThe AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma.  The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.",
      "code_info": "Lot 61275Q100, exp. date: 09/09/08; Lot 58167Q100, exp. date: 08/30/08; Lot 56039Q101, exp. date: 07/13/08; and Lot 56039Q100, exp. date: 07/13/08.",
      "firm_fei_number": "2623532",
      "recalling_firm": "Abbott Diagnostic International, Ltd.",
      "address_1": "Carr # 2 Km 58.0 Cruce Davila",
      "city": "Barceloneta",
      "state": "PR",
      "postal_code": "00617-3009",
      "additional_info_contact": "Saritza Rios\n787-846-3500 Ext. 3352",
      "reason_for_recall": "AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file.\n\nThe instrument might require installation of the AxSYM Digoxin II assay file.",
      "root_cause_description": "Software change control",
      "action": "A Product Information letter, dated May 22, 2008, was issued to customers.  It requested that one of the following two actions be taken if the AxSYM Digoxin II assay file is not installed on your AxSYM instrument and you want to run the AxSYM Digoxin II assay.  If you have one of the previously manufactured software disks listed, [AxSYM Digoxin II Assay Disk, LN 2C43-01, or higher; or AxSYM TDM/Transplant Assay Disk Version 1.0 (3D53-01) or Version 2.0 (3D53-02)], install the AxSYM Digoxin II assay file.  Do not install any other assay file.  If you do not have one of the assay disks listed, contact your local Customer Service representative to have this assay file installed or install the file from a previous version if you have it on hand.",
      "product_quantity": "9069 kits",
      "distribution_pattern": "Worldwide Distribution --- USA including states of AL, AZ, AR, CA, CT, FL, GA, IL, KS, MD, MA, MI, MN, MS, MO, NV, NJ, NY, ND, OK, OR, PA, RI, TX, VA, WA, Hawaii, and Puerto Rico, and countries of Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Chile, Uruguay, Argentina, Puerto Rico, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand, Curacao, and Panama.",
      "openfda": {
        "k_number": [
          "K972794",
          "K951391",
          "K854972",
          "K983151",
          "K153301",
          "K983323",
          "K915602",
          "K831177",
          "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",
          "K914151",
          "K854638",
          "K864333",
          "K963062",
          "K884528",
          "K910642",
          "K973112",
          "K870552",
          "K193397",
          "K894521",
          "K923853",
          "K790521",
          "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": [
          "2432235",
          "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"
      }
    }
  ]
}