BEUDAMED
    FDA Recall Terminated

    COBAS TaqMan analyzer, Series 96; catalog number 8080216.

    Recall: Z-0917-03 · Initiated March 6, 2003

    Recall

    Recall Number
    Z-0917-03
    Event Number
    25949
    Firm
    Roche Molecular Systems Inc
    FEI Number
    1000121742
    Product Code
    JJF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 6, 2003
    Posted
    June 5, 2003
    Terminated
    December 10, 2003
    Address
    11 Franklin Ave, Belleville, NJ, 07109

    Description

    COBAS TaqMan analyzer, Series 96; catalog number 8080216.

    Reason

    A false positive result may be reported.

    Action

    Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.

    Distribution

    Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia.

    Quantity

    16