BEUDAMED
    FDA Recall Terminated

    Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.

    Recall: Z-0919-2007 · Initiated April 30, 2007

    Recall

    Recall Number
    Z-0919-2007
    Event Number
    37796
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 30, 2007
    Posted
    June 9, 2007
    Terminated
    December 17, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.

    Reason

    Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

    Action

    Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.

    Distribution

    Nationwide.

    Quantity

    662