{
  "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": "37971",
      "product_res_number": "Z-0843-05",
      "event_date_initiated": "2005-03-07",
      "event_date_posted": "2005-05-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-10-16",
      "res_event_number": "31482",
      "product_code": "GJS",
      "k_numbers": [
        "K974566"
      ],
      "product_description": "Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704",
      "code_info": "Product numbers 259846, 259847, Lot numbers: 161849, 161800 and 161798. Recall Expanded (03/23/2005)  to include these additional lot numbers: 161655, 161710, 161741, 161738, 161742, 1621739, 161743, 161740, 161764, 161763, 161797 and 161799.",
      "firm_fei_number": "3002769706",
      "recalling_firm": "BIOMERIEUX, INC.",
      "address_1": "100 Rodolphe St",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "John Cusack, Sr.\n919-620-2803",
      "reason_for_recall": "The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct.  The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter on/about March 7, 2005.",
      "product_quantity": "19748 kits",
      "distribution_pattern": "Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand",
      "openfda": {
        "k_number": [
          "K952608",
          "K092987",
          "K884855",
          "K001699",
          "K933252",
          "K180780",
          "K243543",
          "K183255",
          "K231711",
          "K940082",
          "K904454",
          "K874592",
          "K810350",
          "K891169",
          "K013155",
          "K020831",
          "K905857",
          "K972866",
          "K935748",
          "K920767",
          "K940432",
          "K864272",
          "K961938",
          "K093460",
          "K991065",
          "K942884",
          "K922040",
          "K974343",
          "K864273",
          "K905807",
          "K151964",
          "K901325",
          "K020679",
          "K851125",
          "K170960",
          "K840802",
          "K012768",
          "K880566",
          "K864274",
          "K043184",
          "K052124",
          "K896625",
          "K212779",
          "K030845",
          "K213426",
          "K904325",
          "K811784",
          "K974566",
          "K791023",
          "K994100",
          "K022922",
          "K092940",
          "K882456",
          "K870596",
          "K954625",
          "K882214",
          "K893378",
          "K020355",
          "K780203",
          "K903019",
          "K062925",
          "K021190",
          "K955843",
          "K930212",
          "K994006",
          "K945078",
          "K902096",
          "K071041",
          "K832427",
          "K931118",
          "K915746",
          "K093243",
          "K864283",
          "K072727",
          "K020840",
          "K913250",
          "K922565",
          "K040296",
          "K070005",
          "K961835",
          "K885107",
          "K792031",
          "K843535",
          "K911995",
          "K962571",
          "K852484",
          "K951820",
          "K902468",
          "K931117",
          "K913249",
          "K211485",
          "K122584",
          "K860721",
          "K991286",
          "K875062",
          "K180693",
          "K972796",
          "K925492",
          "K230802",
          "K981479",
          "K925604",
          "K872537",
          "K921326",
          "K883441",
          "K992492",
          "K132722",
          "K010599",
          "K872844",
          "K220282",
          "K940310",
          "K060978",
          "K892050",
          "K791022",
          "K180684",
          "K110212",
          "K253188",
          "K891370",
          "K830331",
          "K072920",
          "K912102",
          "K060931",
          "K935702",
          "K003870",
          "K201185",
          "K864392",
          "K021923",
          "K251564"
        ],
        "device_name": "Test, Time, Prothrombin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7750",
        "device_class": "2",
        "registration_number": [
          "2432235",
          "1219029",
          "3013188547",
          "3013298431",
          "3013660430",
          "1835316",
          "9610806",
          "3006198300",
          "3005643513",
          "2431530",
          "3037000637",
          "3011689956",
          "9610126",
          "1618982",
          "2085064",
          "1181121",
          "2245451",
          "3008386529",
          "2245578",
          "3010285483",
          "1217183",
          "3005146313",
          "3003691680",
          "3025915415",
          "9710666",
          "3002721930",
          "3030186688",
          "3007507465",
          "3012302888",
          "1832816",
          "3015499222",
          "3033967997"
        ],
        "fei_number": [
          "2432235",
          "1219029",
          "3002806559",
          "3013188547",
          "3013298431",
          "3013660430",
          "3006198300",
          "3000210416",
          "3005643513",
          "2431530",
          "3037000637",
          "3011689956",
          "1618982",
          "1000135102",
          "1181121",
          "2245451",
          "3008386529",
          "2245578",
          "3010285483",
          "1217183",
          "3005146313",
          "3003565434",
          "3003691680",
          "3025915415",
          "3001644026",
          "2250033",
          "3030186688",
          "3007507465",
          "3012302888",
          "1832816",
          "3015499222",
          "3033967997"
        ]
      }
    }
  ]
}