{
  "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 III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90471",
      "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": "Letter",
      "distribution_pattern": "US Nationwide distribution in the state of IL.",
      "recall_number": "Z-1422-2022",
      "product_description": "Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD",
      "product_quantity": "12 kits (US)",
      "reason_for_recall": "A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the \u001cMath Error\u001d flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.",
      "recall_initiation_date": "20220609",
      "center_classification_date": "20220720",
      "termination_date": "20240208",
      "report_date": "20220727",
      "code_info": "UDI-DI (GTIN): 05055273215564  All lots within expiry"
    }
  ]
}