{
  "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": "Cambridge",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91117",
      "recalling_firm": "Cytocell Ltd.",
      "address_1": "418 Cambridge Science Park, Milton Road",
      "address_2": "Oxford Gene Technology",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "TX",
      "recall_number": "Z-0353-2023",
      "product_description": "CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy.  This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14.  Ref: MPD39781",
      "product_quantity": "",
      "reason_for_recall": "Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert",
      "recall_initiation_date": "20221027",
      "center_classification_date": "20221201",
      "termination_date": "20241227",
      "report_date": "20221207",
      "code_info": "Lot RD22/230/10",
      "more_code_info": ""
    }
  ]
}