BEUDAMED
    FDA Enforcement Class II Ongoing

    Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

    Recall: Z-0590-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-0590-2024
    Event ID
    93467
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 1, 2024
    Initiation Date
    November 20, 2023
    Classification Date
    December 19, 2023
    Address
    Heidelberger Str. 17-19, N/A, Nussloch, N/A, N/A, Germany

    Description

    Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

    Reason

    There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

    Code Info

    All devices with serial number: G0061-G0701

    Distribution

    US, Nationwide

    Quantity

    98 devices