BEUDAMED
    FDA Enforcement Class II Ongoing

    ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

    Recall: Z-1093-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1093-2026
    Event ID
    98058
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2026
    Initiation Date
    December 12, 2025
    Classification Date
    January 15, 2026
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020, United States

    Description

    ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

    Reason

    Fungal contamination of affected lot with Parengyodontium album.

    Code Info

    Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.

    Distribution

    US Nationwide distribution.

    Quantity

    3,728 units