BEUDAMED
    FDA Enforcement Class II 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 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0019-2019
    Event ID
    80986
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Microsystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    September 4, 2018
    Classification Date
    October 3, 2018
    Termination Date
    July 10, 2020
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622, United States

    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.

    Code Info

    Serial Number 102

    Distribution

    Distribution in US state of MO.

    Quantity

    1 unit