BEUDAMED
    FDA Recall Terminated

    Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005

    Recall: Z-1551-2010 · Initiated February 9, 2010

    Recall

    Recall Number
    Z-1551-2010
    Event Number
    54566
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    IEO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2010
    Posted
    May 7, 2010
    Terminated
    June 30, 2011
    Address
    2345 Waukegan Rd, Bannockburn, IL, 60015-1515

    Description

    Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005

    Reason

    Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during processing, leading to rebiopsies.

    Action

    Leica Microsystems sent Medical Device Correction letters dated 2/9/10 to the affected customers via first class mail on the same date, informing them of the potential for tissue damage during processing and outlining the software upgrade being made to minimize the risk of tissue damage. Customers were informed that their local Leica Microsystems representative will contact them to arrange the software upgrade and to provide training on the use of the new software. The letters also provided the necessary steps required to avoid tissue damage during processing while they are awaiting the software upgrade. The accounts were asked to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.

    Distribution

    Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia.

    Quantity

    574 units