{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Kearneysville",
      "address_1": "515 Industrial Blvd",
      "reason_for_recall": "According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product.    As control results will be outside of the quoted range this may result in a delay in reporting the sample test results.     However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice",
      "address_2": "",
      "product_quantity": "198 kits",
      "code_info": "Catalogue number  UC5075  Batch number  907UC",
      "center_classification_date": "20170526",
      "distribution_pattern": "Worldwide Distribution - US Distribution to Puerto Rico and to the countries of :  Canada  Kuwait  Chile  Poland  China  Romania  France  Saudi Arabia  Guatemala  Slovenia  Iran  UAE  India  UK  Italy  Uruguay  Iraq",
      "state": "WV",
      "product_description": "Liquid Urine Control Level 3    For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.",
      "report_date": "20170607",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Randox Laboratories",
      "recall_number": "Z-2167-2017",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "77152",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20170427",
      "postal_code": "25430-2778",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}