BEUDAMED
    FDA Recall Terminated

    Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529

    Recall: Z-1814-2012 · Initiated March 22, 2012

    Recall

    Recall Number
    Z-1814-2012
    Event Number
    61737
    Firm
    Tripath Imaging, Inc.
    FEI Number
    3008007472
    Product Code
    MKQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 22, 2012
    Posted
    June 15, 2012
    Terminated
    December 3, 2012
    Address
    780 Plantation Dr, Burlington, NC, 27215-6723

    Description

    Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529

    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

    Action

    BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.

    Distribution

    Worldwide Distribution.

    Quantity

    46,112,784 for all products in Recall Event