BEUDAMED
    FDA Recall Terminated

    BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.

    Recall: Z-1090-2009 · Initiated September 26, 2008

    Recall

    Recall Number
    Z-1090-2009
    Event Number
    49548
    Firm
    Bd Diagnostic Systems Tripath
    FEI Number
    3004173866
    Product Code
    MKQ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    September 26, 2008
    Posted
    March 19, 2009
    Terminated
    January 15, 2013
    Address
    4025 Stirrup Creek Dr, Durham, NC, 27703-9398

    Description

    BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.

    Reason

    Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.

    Action

    BD Diagnostics began contacting known non-gyn customers by phone on 09/26/2008. Customers were notified by Urgent - Important Product Information letter on 09/29/2008. They were advised to stop using the system until they complete a list of actions provided in the letter. A telephone contact number for Technical Support was provided in the letter. A permanent software based solution will be provided to customers when completed. They anticipate the software will be available in October 2008.

    Distribution

    Worldwide Distribution

    Quantity

    662 units