{
  "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": "2026-04-08",
    "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": "81421",
      "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": "U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,",
      "recall_number": "Z-0604-2019",
      "product_description": "Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S    The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.",
      "product_quantity": "60",
      "reason_for_recall": "Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.",
      "recall_initiation_date": "20181106",
      "center_classification_date": "20181213",
      "termination_date": "20210427",
      "report_date": "20181219",
      "code_info": "Lot 413849"
    }
  ]
}