BEUDAMED
    FDA Recall Terminated

    Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250

    Recall: Z-0688-2008 · Initiated December 3, 2007

    Recall

    Recall Number
    Z-0688-2008
    Event Number
    45910
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JFJ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 3, 2007
    Posted
    February 8, 2008
    Terminated
    June 11, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250

    Reason

    False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.

    Action

    Consignees were sent and Urgent Medical Device Correction notice dated 12/03/07. The notice provided instructions for conducting an additional wash cycle whenever both the LDL-Cholesterol assays and Lipases assay are used on the COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers. Contact Roche Technical Support at 1-800-428-2336 for questions regarding these instructions.

    Distribution

    Nationwide Distribution

    Quantity

    9,817 kits.