{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dundee",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74786",
      "recalling_firm": "BBI SOLUTIONS OEM LTD",
      "address_1": "8 Tom McDonald Avenue",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US distribution to CT and IN",
      "recall_number": "Z-0314-2017",
      "product_description": "SimpliRED D-Dimer, Product Code DSRK4  The 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",
      "product_quantity": "420 units (183 units quarantined)",
      "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.",
      "recall_initiation_date": "20160601",
      "center_classification_date": "20161027",
      "termination_date": "20180614",
      "report_date": "20161102",
      "code_info": "Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B  Expiration Date: 31 JUL 2016",
      "more_code_info": ""
    }
  ]
}