{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Crumlin (North)",
      "state": "N/A",
      "country": "Ireland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90777",
      "recalling_firm": "Randox Laboratories Ltd.",
      "address_1": "55 Diamond Road",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of WV, NC.",
      "recall_number": "Z-1772-2022",
      "product_description": "The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.",
      "product_quantity": "2 units",
      "reason_for_recall": "***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI.  Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg",
      "recall_initiation_date": "20220801",
      "center_classification_date": "20220919",
      "termination_date": "20241213",
      "report_date": "20220928",
      "code_info": "GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023"
    }
  ]
}