{
  "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": "34991",
      "product_res_number": "Z-0042-05",
      "event_date_initiated": "2004-08-27",
      "event_date_posted": "2004-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-05-10",
      "res_event_number": "30005",
      "product_code": "JPA",
      "k_numbers": [
        "K011665"
      ],
      "product_description": "DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.",
      "code_info": "Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832",
      "firm_fei_number": "2517506",
      "recalling_firm": "Dade Behring , Inc.",
      "address_1": "Rte 896, Glasgow Business Community Rte 896 Glasgow Business Community",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702",
      "additional_info_contact": "Donna A. Wolf\n302-631-0384",
      "reason_for_recall": "APTT determinations when using affected rotors may lead to incorrectly shortened times",
      "root_cause_description": "Other",
      "action": "The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established.",
      "product_quantity": "7140 units",
      "distribution_pattern": "The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.",
      "openfda": {
        "k_number": [
          "K761176",
          "K023141",
          "K853328",
          "K161317",
          "K870960",
          "K780810",
          "K253658",
          "K243858",
          "K212183",
          "K050513",
          "K812122",
          "K900917",
          "K083175",
          "K851153",
          "K761172",
          "K926551",
          "K761173",
          "K853789",
          "K933886",
          "K071265",
          "K010494",
          "K160502",
          "K172333",
          "K151259",
          "K883689",
          "K083842",
          "K864532",
          "K173202",
          "K854376",
          "K011665",
          "K853986",
          "K030818",
          "K162688",
          "K990566",
          "K872377",
          "K850409",
          "K770606",
          "K930849",
          "K900377",
          "K761091",
          "K942096",
          "K981815",
          "K061014",
          "K860719",
          "K980839",
          "K862537",
          "K924393",
          "K853077",
          "K083159",
          "K790204",
          "K974569",
          "K233790",
          "K812121",
          "K001064",
          "K894359",
          "K864271",
          "K060162",
          "K161312",
          "K983460",
          "K990449",
          "K964946",
          "K832225",
          "K812124",
          "K860342",
          "K870831",
          "K883635",
          "K923761",
          "K955720",
          "K221359",
          "K854090",
          "K842717",
          "K050243",
          "K984501",
          "K912087",
          "K981711",
          "K082675",
          "K992959",
          "K940401",
          "K870771",
          "K864534",
          "K853246",
          "K040359",
          "K853076",
          "K952625",
          "K000053",
          "K870686",
          "K151867",
          "K083896",
          "K974799",
          "K791586",
          "K902458",
          "K994349",
          "K250965",
          "K851127",
          "K933188",
          "K880713",
          "K925340",
          "K841462",
          "K955735",
          "K893650",
          "K894466",
          "K930068",
          "K232018",
          "K002177",
          "K841523",
          "K853198",
          "K924124",
          "K993678",
          "K961908",
          "K761175",
          "K914188",
          "K930454",
          "K883637",
          "K093167",
          "K020798",
          "K854546",
          "K870688",
          "K885076",
          "K926222",
          "K983892",
          "K931149",
          "K183390",
          "K170314",
          "K251024",
          "K951497",
          "K934747",
          "K954202",
          "K833272",
          "K000973",
          "K870687",
          "K883484",
          "K162420",
          "K875089",
          "K940840",
          "K951891",
          "K761171",
          "K150041",
          "K881367",
          "K082248",
          "K050016",
          "K884534",
          "K960875",
          "K202101",
          "K972260",
          "K050053",
          "K083518",
          "K790323",
          "K854938",
          "K882444",
          "K150678",
          "K051030",
          "K033137",
          "K093001",
          "K011235",
          "K952560",
          "K854089",
          "K002080",
          "K101533",
          "K940957",
          "K172286",
          "K001067",
          "K760594",
          "K193041",
          "K013114",
          "K870685",
          "K900506",
          "K942097",
          "K924453",
          "K792310",
          "K002400",
          "K970431",
          "K130090",
          "K021162",
          "K924509",
          "K883640",
          "K852450",
          "K853078",
          "K183160",
          "K912061",
          "K201440",
          "K955724"
        ],
        "registration_number": [
          "3004035727",
          "1719400",
          "3009711478",
          "8043723",
          "3007507465",
          "8020030",
          "1644474",
          "9610806",
          "3005269352",
          "3002721930",
          "2245451",
          "3019849102",
          "2026994",
          "2184009",
          "1217183",
          "9610746",
          "3010653929",
          "1220649",
          "3037000637",
          "3003943960",
          "3010421384",
          "1219343",
          "9613959",
          "1000340866",
          "3003601075",
          "3007719797",
          "1219738",
          "2431530",
          "3020704087",
          "3005792925",
          "3008386529",
          "2432235",
          "3015222335",
          "3012348571",
          "2132111",
          "1718389",
          "3006198300",
          "1618982",
          "3007701696",
          "3010960914"
        ],
        "fei_number": [
          "3006461677",
          "3004035727",
          "1719400",
          "3001573851",
          "3009711478",
          "3007507465",
          "3005269352",
          "2250033",
          "2245451",
          "3002808301",
          "3019849102",
          "2026994",
          "1217183",
          "3010653929",
          "1220649",
          "3037000637",
          "3003943960",
          "3010421384",
          "3002806557",
          "1219343",
          "1000116989",
          "1000340866",
          "1000140026",
          "3001644026",
          "3003601075",
          "3007719797",
          "1219738",
          "2431530",
          "3020704087",
          "3005792925",
          "3008386529",
          "2432235",
          "3015222335",
          "3012348571",
          "1000116158",
          "1718389",
          "3006198300",
          "1618982",
          "3007701696",
          "3010960914"
        ],
        "device_name": "System, Multipurpose For In Vitro Coagulation Studies",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5425",
        "device_class": "2"
      }
    }
  ]
}