{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48950",
      "product_res_number": "Z-0227-2007",
      "event_date_initiated": "2006-10-18",
      "event_date_posted": "2006-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-06-20",
      "res_event_number": "36587",
      "product_code": "GJS",
      "k_numbers": [
        "K930454",
        "K962571",
        "K974569",
        "K994349"
      ],
      "product_description": "CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 [packaged 12 strips per box].",
      "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": "800-820-0995",
      "reason_for_recall": "Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.",
      "root_cause_description": "Other",
      "action": "A press release was issued by the firm on 10/19/06.  The recall letter dated 10/19/06 sent to distributors who sell to home users instructs them to notify their home users and to discard any of product 3116239 in stock.  The recall letter dated 10/19/06 to to home users, instructs them to discontinue use of, and to discard, their test strips and to contact their health care professional.  The device correction letter dated 10/19/06 to distributors to professional users instructs them to notify customers and provides instructions for duplicate testing in laboratories.  The device correction letter dated 10/19/06 to health care professionals asks that they follow-up with their home users to ensure they follow the instructions to cease home use and provides instructions for dupicate testing in laboratories.",
      "product_quantity": "Approx 26,000,000 test strips to U.S. and 31,000,000 test strips Ex-U.S.",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "k_number": [
          "K212779",
          "K903019",
          "K093460",
          "K183255",
          "K954625",
          "K093243",
          "K892050",
          "K875062",
          "K901325",
          "K791022",
          "K893378",
          "K001699",
          "K981479",
          "K913249",
          "K974566",
          "K902096",
          "K974343",
          "K991065",
          "K003870",
          "K942884",
          "K180684",
          "K060978",
          "K122584",
          "K013155",
          "K884855",
          "K955843",
          "K930212",
          "K864392",
          "K940310",
          "K231711",
          "K012768",
          "K912102",
          "K030845",
          "K933252",
          "K945078",
          "K791023",
          "K020831",
          "K961938",
          "K780203",
          "K840802",
          "K896625",
          "K880566",
          "K931118",
          "K925604",
          "K832427",
          "K904454",
          "K872537",
          "K072920",
          "K972796",
          "K921326",
          "K830331",
          "K872844",
          "K860721",
          "K864283",
          "K902468",
          "K915746",
          "K062925",
          "K864272",
          "K852484",
          "K904325",
          "K180780",
          "K920767",
          "K883441",
          "K020679",
          "K211485",
          "K180693",
          "K962571",
          "K811784",
          "K170960",
          "K043184",
          "K022922",
          "K792031",
          "K021923",
          "K020840",
          "K060931",
          "K010599",
          "K070005",
          "K213426",
          "K952608",
          "K913250",
          "K994006",
          "K991286",
          "K994100",
          "K110212",
          "K882456",
          "K092940",
          "K021190",
          "K092987",
          "K961835",
          "K922565",
          "K864273",
          "K992492",
          "K935748",
          "K071041",
          "K940432",
          "K972866",
          "K052124",
          "K230802",
          "K151964",
          "K040296",
          "K201185",
          "K072727",
          "K220282",
          "K243543",
          "K874592",
          "K905857",
          "K911995",
          "K253188",
          "K885107",
          "K020355",
          "K864274",
          "K870596",
          "K132722",
          "K940082",
          "K891370",
          "K951820",
          "K891169",
          "K905807",
          "K882214",
          "K931117",
          "K810350",
          "K935702",
          "K851125",
          "K925492",
          "K922040",
          "K251564",
          "K843535"
        ],
        "device_name": "Test, Time, Prothrombin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7750",
        "device_class": "2",
        "registration_number": [
          "3005643513",
          "3015499222",
          "3013188547",
          "3033967997",
          "1832816",
          "3011689956",
          "2431530",
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          "9610126",
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          "3010285483",
          "3037000637",
          "1835316",
          "2085064",
          "3030186688",
          "3006198300",
          "3008386529"
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        "fei_number": [
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          "1000135102"
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    }
  ]
}