BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2112-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2112-2013
    Event ID
    65779
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 8, 2013
    Classification Date
    August 28, 2013
    Termination Date
    May 1, 2014
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    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.

    Code Info

    Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)

    Distribution

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

    Quantity

    890 instruments