BEUDAMED
    FDA Recall Terminated

    Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)

    Recall: Z-0918-2007 · Initiated April 5, 2007

    Recall

    Recall Number
    Z-0918-2007
    Event Number
    37795
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    KLB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2007
    Posted
    June 9, 2007
    Terminated
    April 30, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)

    Reason

    Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.

    Action

    Foreign affiliates were notified via email letter dated 4/5/07 requesting that to notify their customers of the need to implement a special wash cycle to prevent reagent carry over.

    Distribution

    International Distribution ONLY-Australia, Canada and Germany.

    Quantity

    474 total (Z-0917-0918-2007)