BEUDAMED
    FDA Enforcement Class II Terminated

    PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.

    Recall: Z-0287-2013 · Reported November 21, 2012

    Enforcement

    Recall Number
    Z-0287-2013
    Event ID
    53336
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dako North America Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2012
    Initiation Date
    May 1, 2008
    Classification Date
    November 13, 2012
    Termination Date
    November 13, 2012
    Address
    6392 Via Real, Carpinteria, CA, 93013-2921, United States

    Description

    PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.

    Reason

    Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.

    Code Info

    Catalog #: PT-Module

    Distribution

    Nationwide distribution: USA including states of: AK, CA, CO, CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA.

    Quantity

    136 units