{
  "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": "148459",
      "product_res_number": "Z-0314-2017",
      "event_date_initiated": "2016-06-01",
      "event_date_created": "2016-10-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-06-14",
      "res_event_number": "74786",
      "product_code": "GHH",
      "k_numbers": [
        "K905643"
      ],
      "product_description": "SimpliRED D-Dimer, Product Code DSRK4\nThe SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood",
      "code_info": "Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016",
      "firm_fei_number": "3012801636",
      "recalling_firm": "BBI SOLUTIONS OEM LTD",
      "address_1": "8 Tom McDonald Avenue",
      "city": "Dundee",
      "country": "United Kingdom",
      "reason_for_recall": "A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life.  Qualitative results may be affected.  False negative results are possible which may incorrectly influence the clinical diagnostic decision.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "BBI Solutions sent an Urgent Medical Device Recall letter dated June 30, 2016, to all affected customers.   Customers were advised to immediately discontinue use of the product, consider the requirement for review of reported test results, complete and return the customer acknowledgement form to BBI Solutions and to complete and return the customer reconciliation form to the distributor.  Customers who have forwarded product to other sites, should inform those customers of the product recall and provide them with a copy  of the notice.  Customers with questions were instructed to call Tel: +44(0)1382 564093.",
      "product_quantity": "420 units (183 units quarantined)",
      "distribution_pattern": "US distribution to CT and IN",
      "openfda": {
        "k_number": [
          "K852520",
          "K852176",
          "K890399",
          "K872360",
          "K021877",
          "K801841",
          "K905643",
          "K112120",
          "K945642",
          "K072288",
          "K861973",
          "K890422",
          "K920668",
          "K070453",
          "K972316",
          "K011143",
          "K921989",
          "K030740",
          "K062203",
          "K812298",
          "K993276",
          "K852512",
          "K042890",
          "K852848",
          "K842277",
          "K791358",
          "K893961",
          "K880077"
        ],
        "registration_number": [
          "3002637618",
          "9610987",
          "3003795116",
          "2245451",
          "9612316",
          "3014353045",
          "9710666",
          "2435505",
          "9610529",
          "3013982035",
          "2032900",
          "9610126",
          "3013660430",
          "2084025",
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          "8031673",
          "3003985394",
          "2032839",
          "9680746",
          "3029973107",
          "2517506",
          "3006198300"
        ],
        "fei_number": [
          "1000119795",
          "3002637618",
          "3003795116",
          "3002808328",
          "2245451",
          "3014353045",
          "2967",
          "3003565434",
          "3004185580",
          "3013982035",
          "1000206808",
          "3013660430",
          "2084025",
          "1181121",
          "3002807710",
          "3003985394",
          "3002806560",
          "3029973107",
          "2517506",
          "3006198300",
          "3002806559",
          "3004445302"
        ],
        "device_name": "Fibrin Split Products",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2"
      }
    }
  ]
}