{
  "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": "91097",
      "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: CA, NC, NJ and WV,",
      "recall_number": "Z-0362-2023",
      "product_description": "IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma  Catalog Number: IA3832",
      "product_quantity": "20 kits US in total",
      "reason_for_recall": "Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in  running patient samples or erroneous elevated test results",
      "recall_initiation_date": "20221101",
      "center_classification_date": "20221202",
      "termination_date": "20240618",
      "report_date": "20221214",
      "code_info": "GTIN: 05055273203882 All lots"
    }
  ]
}