BEUDAMED
    FDA Enforcement Class II Ongoing

    Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples

    Recall: Z-0086-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0086-2025
    Event ID
    95323
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    September 4, 2024
    Classification Date
    October 15, 2024
    Address
    Heidelberger Str. 17-19, Nussloch, N/A, Germany

    Description

    Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples

    Reason

    As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

    Code Info

    a) Material Number 1491510C002, UDI/DI (01)04049188002945, Serial Numbers: 5359022006, 5367012006, 5913, 5996, 5065, 5625022007, 5467072006, 5901, 5108122004, 5330, 5269, 5667; b) Material Number 1491510C003, UDI/DI (01)04049188002891. Serial Numbers: 5537

    Distribution

    US Nationwide distribution.

    Quantity

    13 units