BEUDAMED
    FDA Recall Terminated

    Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems Inc, Tucson, AZ

    Recall: Z-0540-2008 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0540-2008
    Event Number
    45496
    Firm
    Ventana Medical Systems Inc
    FEI Number
    1000125183
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 29, 2006
    Posted
    January 24, 2008
    Terminated
    June 6, 2013
    Address
    1910 E Innovation Park Dr, Tucson, AZ, 85755-1962

    Description

    Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems Inc, Tucson, AZ

    Reason

    Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.

    Action

    The firm has mailed three customer letters, a) the first letter dated 9/30/2005 describes the upgraded Voila CD that contains safety information; b) a second letter, dated 6/27/2006, identified as a "Customer Alert" was mailed describing an upgrade to the software system version 9.3/10.3 and the CD that includes safety improvements, c) the third letter dated 9/29/2006 and identified as a Safety Alert advises that as part of their effort to continuously improve laboratory safety, they are updating the labeling and instructions for use regarding installation and cleaning for the carboy as the Ventana staining platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. Enclosed are pictogram labels that indicate "slip hazard" and "refer to instructions for use." The customer is instructed to apply these two labels to the carboys above the spigot as a reminder to laboratory personnel to keep the spigot in the full "off" position when not in use and to refer to the instructions for use for maintenance. In addition, the letter advises that there is an electrical shock warning for the power strip that is part of their system to indicate that it should be mounted off of the floor. This power strip is intended to connect the computer components of the staining system and should not be placed on the floor where fluid might contact it. Also included is a warning label for shock hazard to apply to their power strip.

    Distribution

    Worldwide; USA, Australia, China, Canada, Germany, Great Britain, France, Italy, Hungary, Singapore, Korea, Taiwan, Spain, Poland, Greece, Austria, Sweden, Japan, Israel, Denmark, Turkey, Finland, Saudi Arabia, The Netherlands, Norway, Slovenia, Ireland, and Belgium

    Quantity

    USA - 1,712 units; Foreign - 1,159 units (total for recalls-Z-0537-0541-2008)