{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217515",
      "product_res_number": "Z-1093-2026",
      "event_date_initiated": "2025-12-12",
      "event_date_posted": "2026-01-15",
      "recall_status": "Open, Classified",
      "res_event_number": "98058",
      "product_code": "LEA",
      "product_description": "ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.",
      "code_info": "Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.",
      "firm_fei_number": "1000120743",
      "recalling_firm": "Hologic, Inc",
      "address_1": "250 Campus Dr",
      "city": "Marlborough",
      "state": "MA",
      "postal_code": "01752-3020",
      "additional_info_contact": "ThinPrep Technical Support\n+1-800-4429892 Ext. 1",
      "reason_for_recall": "Fungal contamination of affected lot with Parengyodontium album.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An URGENT MEDICAL DEVICE RECALL NOTIFICATION was mailed to consignees on 12/12/25. The notification informs consignees that Hologic will provide replacement bottles of ThinPrep CytoLyt Solution to affected customers from unaffected lots based on retained sample testing. Consignees are asked to inspect their inventory for affected product and discontinue use immediately. Affected product is to be quarantined and destroyed per routine laboratory disposal procedures. Consignees are asked to complete the Customer Response Form using the provided QR Code and Hologic will coordinate replacement. Consignees can contact IQVIA MedTech for assistance with response forms at 855-620-6108 or by email at hologic-fa00286@iqvia.com. Consignees with questions about the recall notice are to contact their local Hologic Technical Support Representative.",
      "product_quantity": "3,728 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K770592",
          "K873594",
          "K761001",
          "K761000"
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        ],
        "device_name": "Preservative, Cytological",
        "medical_specialty_description": "Pathology",
        "regulation_number": "864.4010",
        "device_class": "1"
      }
    }
  ]
}