BEUDAMED
    FDA Recall 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 · Initiated May 1, 2008

    Recall

    Recall Number
    Z-0287-2013
    Event Number
    53336
    Firm
    Dako North America Inc.
    FEI Number
    2022180
    Product Code
    IDY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 1, 2008
    Posted
    November 13, 2012
    Terminated
    November 13, 2012
    Address
    6392 Via Real, Carpinteria, CA, 93013-2921

    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.

    Action

    The firm, Dako, sent a "DAKO PT LINK ADVISORY NOTICE" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard. The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. Customers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.

    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