BEUDAMED
    FDA Recall Open, Classified

    Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples

    Recall: Z-0088-2025 · Initiated September 4, 2024

    Recall

    Recall Number
    Z-0088-2025
    Event Number
    95323
    Firm
    LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany
    FEI Number
    3002179321
    Product Code
    IDP
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    September 4, 2024
    Posted
    October 15, 2024

    Description

    Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; 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.

    Action

    Leica Biosystems issued an Urgent Field Action Notice to its consignees on 09/05/2024 via mail. The notice explained the problem with the device and requested the placement of a warning sticker regarding the use of flammable freezing sprays on the device and the addition of a supplemental sheet to the current IFU. For questions, please contact: Heather Jensen, Leica Biosystems, 5205 US Highway 12, Richmond, IL 60071 USA, Tel.: +1-815-298-8371, [email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    25 units