BEUDAMED
    FDA Recall Terminated

    Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

    Recall: Z-0019-2019 · Initiated September 4, 2018

    Recall

    Recall Number
    Z-0019-2019
    Event Number
    80986
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    KIM
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 4, 2018
    Terminated
    July 10, 2020
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

    Reason

    Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.

    Action

    The firm issued a Field Action Notice by letter on 09/05/2018. The notice explained the issue and the possible hazard. The firm will schedule a visit with a service engineer to perform the correction.

    Distribution

    Distribution in US state of MO.

    Quantity

    1 unit