BEUDAMED
    FDA Recall Terminated

    COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.

    Recall: Z-0762-2013 · Initiated November 28, 2012

    Recall

    Recall Number
    Z-0762-2013
    Event Number
    63997
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    MWA
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 28, 2012
    Posted
    January 31, 2013
    Terminated
    August 6, 2015
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.

    Reason

    The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.

    Action

    Roche issued Product Advisory Notice (PAN) 2012-11 and Urgent Field Safety Notice PAN 2012-11 by email to Local Safety Officers (LSO) and General/Country Managers from all countries on 28-Nov-2012. The notice identifed the affected product, problem and actions to be taken. LSOs are to provide the information in the Field Safety Notice (FSN) to each customer and return a Feedback Form to Roche (email address: [email protected]) once actions in FSN are executed.

    Distribution

    Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)

    Quantity

    335 CE-IVD TDFs; 48 JPN-IVD TDFs