{
  "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": "37744",
      "product_res_number": "Z-0098-06",
      "event_date_initiated": "2005-03-28",
      "event_date_posted": "2005-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-04-06",
      "res_event_number": "31372",
      "product_code": "GJS",
      "k_numbers": [
        "K021190",
        "K030845",
        "K962571"
      ],
      "product_description": "Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.",
      "code_info": "All lots.",
      "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": "800-428-4674",
      "reason_for_recall": "Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.",
      "root_cause_description": "Other",
      "action": "Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.",
      "product_quantity": "unknown.",
      "distribution_pattern": "Nationwide.",
      "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"
        ]
      }
    }
  ]
}