BEUDAMED
    FDA Recall Terminated

    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.

    Recall: Z-2209-2012 · Initiated February 1, 2012

    Recall

    Recall Number
    Z-2209-2012
    Event Number
    62586
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    JJF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 1, 2012
    Posted
    August 15, 2012
    Terminated
    July 16, 2013
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.

    Reason

    Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if the issue occurs, but samples in proce

    Action

    On 1/17/2012 an "Analyzer Bulletin" notification was sent to Roche affiliates and on 2/1/2012 an "Analyzer Bulletin" notification was sent to all affected US Consignees. The notification described the product issue and provided recommended actions. Customers were referred to Roche Technical Support at 800-526-1247 for questions.

    Distribution

    Nationwide Distribution (USA).

    Quantity

    2,132 boxes