BEUDAMED
    FDA Enforcement Class II Ongoing

    Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

    Recall: Z-1947-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-1947-2024
    Event ID
    94470
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2024
    Initiation Date
    April 10, 2024
    Classification Date
    June 4, 2024
    Address
    Heidelberger Str. 17-19, N/A, Nussloch, N/A, N/A, Germany

    Description

    Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

    Reason

    Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.

    Code Info

    All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, TN, TX, UT, VA, WA, and WI. There was also government distribution but no military distribution. The country of Canada.

    Quantity

    141 devices