BEUDAMED
    FDA Enforcement Class II Terminated

    Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.

    Recall: Z-1261-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1261-2015
    Event ID
    70558
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dako North America Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    February 12, 2015
    Classification Date
    March 10, 2015
    Termination Date
    February 11, 2016
    Address
    6392 Via Real, N/A, Carpinteria, CA, 93013-2921, United States

    Description

    Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.

    Reason

    A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.

    Code Info

    992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C Affected dates: 12/2013-08/2014 Each device is labeled with a unique serial number. Catalog/Model Number: - AS480 - S3800 - S3400 - AS100

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.

    Quantity

    409