BEUDAMED
    FDA Recall Terminated

    BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.

    Recall: Z-0003-2008 · Initiated May 2, 2007

    Recall

    Recall Number
    Z-0003-2008
    Event Number
    38430
    Firm
    Meretek Diagnostics, Inc.
    FEI Number
    3000210499
    Product Code
    MSQ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    May 2, 2007
    Posted
    October 4, 2007
    Terminated
    November 26, 2007
    Address
    2655 Crescent Drive, Suite C, Lafayette, CO, 80026

    Description

    BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.

    Reason

    Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

    Action

    Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.

    Distribution

    Nationwide.

    Quantity

    92 units