{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "49723",
      "product_res_number": "Z-0364-2007",
      "event_date_initiated": "2006-12-12",
      "event_date_posted": "2007-01-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-08-15",
      "res_event_number": "36991",
      "product_code": "GJS",
      "k_numbers": [
        "K020355"
      ],
      "product_description": "i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. \nRef 04J50-01  \n24\nIVD\nAbbott Point of Care Inc.\n104 Windsor Center Drive\nEast Windsor, NJ 08520\n\nProduct of Canada",
      "code_info": "Product list #''s 04J50-01 and 04J50-02, catalog # 420200  Lot numbers: N06227, N06175A, N06176, N06179, N06181, N06186,  N06188,, N06194, N06195A, N06200A, N06201A, N06201B, N06201C, N06202, N06206, N06206B, N06208, N06208A, N06209, N06222, N06222A, N06222B, N06223, N06227, N06227A, N06227B, N06235, N06235A, N06236A, N06236B, N06237, N06241, N06241A, N06241B, N06243, N06244, N06251, N06254, N06256, N06258C, N06262, N06263, N06265, N06265A, N06265B, N06265C, N06265D, N06265E, N06266, N06266A, N06267, N06268, N06268A, N06269, N06269A, N06273, N06274, N06274A, N06274B, N06274C, N06275, N06275A, N06275B, N06275C, N06276, N06277, N06277A, N06277B, N06282, N06285, N06285B, N06285C, N06290A,  N06294, N06294A, N06295, N06298, N06298A, N06298B, N06301A, N06303,  N06304,  N06308, N06309, N06310A, N06311,",
      "firm_fei_number": "2245578",
      "recalling_firm": "Abbott Point of Care Inc.",
      "address_1": "104 Windsor Center Dr",
      "city": "East Windsor",
      "state": "NJ",
      "postal_code": "08520-1407",
      "additional_info_contact": "Paul VanDerWerf\n609-443-9300",
      "reason_for_recall": "Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.",
      "root_cause_description": "Other",
      "action": "Customers were notified by letter sent by regular mail on 12/13/2006.",
      "product_quantity": "14,045 boxes of 24",
      "distribution_pattern": "Nationwide to hospitals and health care facilities",
      "openfda": {
        "k_number": [
          "K092987",
          "K231711",
          "K972796",
          "K885107",
          "K902468",
          "K092940",
          "K931117",
          "K810350",
          "K893378",
          "K901325",
          "K201185",
          "K951820",
          "K780203",
          "K920767",
          "K791023",
          "K955843",
          "K913250",
          "K994006",
          "K843535",
          "K052124",
          "K243543",
          "K072920",
          "K942884",
          "K935748",
          "K060931",
          "K021923",
          "K060978",
          "K832427",
          "K170960",
          "K220282",
          "K904454",
          "K930212",
          "K072727",
          "K921326",
          "K882214",
          "K903019",
          "K840802",
          "K070005",
          "K211485",
          "K180684",
          "K905857",
          "K093460",
          "K043184",
          "K884855",
          "K896625",
          "K925492",
          "K911995",
          "K122584",
          "K213426",
          "K864283",
          "K012768",
          "K864272",
          "K062925",
          "K992492",
          "K961938",
          "K811784",
          "K952608",
          "K251564",
          "K945078",
          "K994100",
          "K882456",
          "K935702",
          "K874592",
          "K872537",
          "K962571",
          "K991286",
          "K230802",
          "K183255",
          "K021190",
          "K872844",
          "K864274",
          "K891169",
          "K791022",
          "K913249",
          "K071041",
          "K940310",
          "K922040",
          "K991065",
          "K915746",
          "K954625",
          "K891370",
          "K003870",
          "K922565",
          "K940082",
          "K180693",
          "K883441",
          "K974343",
          "K852484",
          "K020840",
          "K020831",
          "K931118",
          "K020355",
          "K212779",
          "K180780",
          "K022922",
          "K981479",
          "K974566",
          "K010599",
          "K860721",
          "K030845",
          "K933252",
          "K904325",
          "K093243",
          "K880566",
          "K110212",
          "K001699",
          "K851125",
          "K905807",
          "K870596",
          "K020679",
          "K864392",
          "K961835",
          "K902096",
          "K132722",
          "K972866",
          "K013155",
          "K875062",
          "K864273",
          "K792031",
          "K151964",
          "K040296",
          "K940432",
          "K830331",
          "K925604",
          "K892050",
          "K253188",
          "K912102"
        ],
        "device_name": "Test, Time, Prothrombin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7750",
        "device_class": "2",
        "registration_number": [
          "3010285483",
          "3007507465",
          "3013660430",
          "3011689956",
          "9610806",
          "1219029",
          "3013188547",
          "3005643513",
          "1832816",
          "3002721930",
          "9610126",
          "2245451",
          "1835316",
          "3005146313",
          "1217183",
          "3013298431",
          "9710666",
          "3030186688",
          "3037000637",
          "3025915415",
          "3012302888",
          "3015499222",
          "2245578",
          "3033967997",
          "2431530",
          "2432235",
          "3008386529",
          "1181121",
          "2085064",
          "3006198300",
          "3003691680",
          "1618982"
        ],
        "fei_number": [
          "1000135102",
          "3010285483",
          "3007507465",
          "3013660430",
          "3011689956",
          "1219029",
          "2250033",
          "3003565434",
          "3013188547",
          "3005643513",
          "1832816",
          "2245451",
          "3005146313",
          "1217183",
          "3013298431",
          "3002806559",
          "3030186688",
          "3037000637",
          "3025915415",
          "3012302888",
          "3001644026",
          "3015499222",
          "2245578",
          "3033967997",
          "2431530",
          "2432235",
          "3008386529",
          "1181121",
          "3003691680",
          "3006198300",
          "3000210416",
          "1618982"
        ]
      }
    }
  ]
}