{
  "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": "2026-08-05",
    "results": {
      "skip": 100,
      "limit": 1,
      "total": 39677
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Crumlin (North)",
      "state": "N/A",
      "country": "Ireland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92650",
      "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 CA, DC, GA, OH, OK, MN, MO, NJ, VA  and Puerto Rico.",
      "recall_number": "Z-2362-2023",
      "product_description": "Randox RX Series  Urea Enzymatic Kinetic Assay  Ref. Numbers:  (1) UR3825\t  (2) UR3873\t  (3) UR8334\t  (4) UR8070 (Modena)",
      "product_quantity": "37 US  194 PR",
      "reason_for_recall": "Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.",
      "recall_initiation_date": "20230613",
      "center_classification_date": "20230809",
      "report_date": "20230816",
      "code_info": "Catalogue Number/GTIN (1) UR3825 05055273206906;  (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594.  Not Batch Specific."
    }
  ]
}