BEUDAMED
    FDA Recall Terminated

    Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

    Recall: Z-0046-2020 · Initiated December 10, 2018

    Recall

    Recall Number
    Z-0046-2020
    Event Number
    83383
    Firm
    Leica Biosystems Imaging, Inc.
    FEI Number
    3006791373
    Product Code
    NOT
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 10, 2018
    Posted
    October 4, 2019
    Terminated
    April 28, 2021
    Address
    1360 Park Center Dr, Vista, CA, 92081-8300

    Description

    Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

    Reason

    The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.

    Action

    The consignees were notified beginning on 12/10/2018 via letter delivered by email.

    Distribution

    There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.

    Quantity

    3 devices