BEUDAMED
    FDA Enforcement Class III Terminated

    PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

    Recall: Z-1813-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1813-2012
    Event ID
    61737
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tripath Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    March 22, 2012
    Classification Date
    June 15, 2012
    Termination Date
    December 3, 2012
    Address
    780 Plantation Dr, N/A, Burlington, NC, 27215-6723, United States

    Description

    PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

    Reason

    The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

    Code Info

    100917ry, 101105sh, 110107rg

    Distribution

    Worldwide Distribution.

    Quantity

    46,112,784 for all products in Recall Event