{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "184625",
      "product_res_number": "Z-0546-2021",
      "event_date_initiated": "2020-11-13",
      "event_date_created": "2020-12-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-01",
      "res_event_number": "86827",
      "product_code": "JGJ",
      "k_numbers": [
        "K974606"
      ],
      "product_description": "Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine\nCatalogue Number: MG3880",
      "code_info": "Lot Number: 539734, Exp Date: 28 March 2022  UDI: 05055273204629",
      "firm_fei_number": "1000361607",
      "recalling_firm": "Randox Laboratories Ltd.",
      "address_1": "55 Diamond Road",
      "city": "Crumlin",
      "state": "North",
      "country": "Ireland",
      "reason_for_recall": "Failing to meet the linearity performance claims\nquoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine",
      "root_cause_description": "Under Investigation by firm",
      "action": "Randox issued Urgent Medical Device Correction letter via e-mail to US Customers on 13 November 2020 stating reason for recall, health risk and action to take:\nDiscontinue use of and discard any of the above immediately.\n\" Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory.\n\" Review results generated with the affected batches in line with the clinical profile of the patient.\n\" Discuss the contents of this notice with your Medical Director.\n\" Complete and return the response form 12187-QA to technical. services@randox.com within five working days.\n\nQuestions or concerns, please contact Randox Technical Services.",
      "product_quantity": "1 kit",
      "distribution_pattern": "US Nationwide distribution in the states of GA, NJ.",
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        "device_name": "Photometric Method, Magnesium",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1495",
        "device_class": "1"
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    }
  ]
}