BEUDAMED
    FDA Recall Terminated

    PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.

    Recall: Z-2112-2013 · Initiated July 8, 2013

    Recall

    Recall Number
    Z-2112-2013
    Event Number
    65779
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    MKQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 8, 2013
    Posted
    August 28, 2013
    Terminated
    May 1, 2014
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.

    Reason

    PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

    Action

    Ex-US BD sites were notified via email and teleconference, and will communicate directly with customer sites in their region as required by local regulation. All US customers were initially contacted via telephone and letters were mailed.

    Distribution

    Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.

    Quantity

    890 instruments