BEUDAMED
    FDA Recall Terminated

    Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.

    Recall: Z-1815-2013 · Initiated November 13, 2012

    Recall

    Recall Number
    Z-1815-2013
    Event Number
    63935
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    IEO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 13, 2012
    Posted
    July 29, 2013
    Terminated
    January 5, 2017
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.

    Reason

    The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.

    Action

    Leica Biosystems sent an Urgent Field Safety Notice dated December 12, 2012, to all affected customers. The notification included a description of the problem and a recommendation that the personnel who use the equipment only use Leica Ready To Use (RTU) bottles that are already supplied as a standard delivery item with the ASP6025 machine. The personnel are further reminded that reagent bottle levels need to be checked and corrected when necessary. Customers with questions or questions regarding this recall call 847-405-5413.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, and United Kingdom.

    Quantity

    128 machines