{
  "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": "2026-08-15",
    "results": {
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      "cfres_id": "196770",
      "product_res_number": "Z-0341-2023",
      "event_date_initiated": "2022-10-27",
      "event_date_posted": "2022-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-12-27",
      "res_event_number": "91119",
      "product_code": "MVU",
      "product_description": "CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent\nRef: MPD39782",
      "code_info": "Lot Number: RD22/230/11",
      "firm_fei_number": "3002646096",
      "recalling_firm": "Cytocell Ltd.",
      "address_1": "418 Cambridge Science Park, Milton Road 418 gene technology cambridge science park milton road",
      "city": "Cambridge",
      "country": "United Kingdom",
      "reason_for_recall": "An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.",
      "root_cause_description": "Under Investigation by firm",
      "action": "CytoCell issued Urgent Medical Device Recall letter on 10/27/22 to end user via email. The letter states reason for recall, health risk and action to take:\nImmediately examine your inventory and quarantine all product subject to recall.\nCytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert.\n\nPlease complete and return the enclosed response form as soon as possible.\nIf you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.",
      "product_quantity": "3 units",
      "distribution_pattern": "TX",
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