BEUDAMED
    FDA Recall Terminated

    Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.

    Recall: Z-0012-2009 · Initiated June 11, 2008

    Recall

    Recall Number
    Z-0012-2009
    Event Number
    48638
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CGX
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    June 11, 2008
    Posted
    October 9, 2008
    Terminated
    September 22, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.

    Reason

    Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

    Action

    Consignees were notified via an Urgent Medical Device correction letter dated 6/11/08 informing users of the problem and providing them with work-around instructions. The instructions suggests 1) inserting the cassette rack slowly; 2) using mainly reagent slots A, B, or C; 3) tilting the rack slightly clockwise so the barcode scanner does not read the barcode at an exact 90 degree angle; and 4) confirming the rack is properly seated on the track and displayed on the Cassette Status screen. If the cassette barcode does not register after following the Work-Around instructions, then customers are required to contact Diagnostics Technical Support.

    Distribution

    Nationwide Distribution

    Quantity

    2