{
  "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": "",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84899",
      "recalling_firm": "The Binding Site Group, Ltd.",
      "address_1": "8 Calthorpe Road",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of M.A., C.A., MO., NC, MN, VA, WA, and IL and country of Canada.",
      "recall_number": "Z-1469-2020",
      "product_description": "VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.",
      "product_quantity": "462 kits",
      "reason_for_recall": "A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with falsely elevated results incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency.",
      "recall_initiation_date": "20180812",
      "center_classification_date": "20200311",
      "termination_date": "20220120",
      "report_date": "20200318",
      "code_info": "UDI: 05051700006767.  Lot numbers 413170 and 435314.",
      "more_code_info": ""
    }
  ]
}