{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Birmingham",
      "state": "N/A",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85366",
      "recalling_firm": "The Binding Site Group, Ltd.",
      "address_1": "8 Calthorpe Road",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US:  AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI  OUS:  None",
      "recall_number": "Z-2110-2020",
      "product_description": "Optilite Optilite Rheumatoid Factor Kit, Ref:  LK151.OPT.A, IVD, Rx Only, UDI:  05051700020015 (kit ea. containing four components)",
      "product_quantity": "478 kits",
      "reason_for_recall": "Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum.  This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.",
      "recall_initiation_date": "20191007",
      "center_classification_date": "20200522",
      "termination_date": "20220111",
      "report_date": "20200603",
      "code_info": "Kit Lot Number:  428224"
    }
  ]
}