BEUDAMED
    FDA Enforcement Class II Terminated

    Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.

    Recall: Z-0064-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0064-2019
    Event ID
    80916
    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
    June 13, 2018
    Classification Date
    October 3, 2018
    Termination Date
    March 18, 2019
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622, United States

    Description

    Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.

    Reason

    These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.

    Code Info

    Serial Numbers: 70-78, 111-112, 120-175

    Distribution

    Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND

    Quantity

    67 units