BEUDAMED
    FDA Enforcement Class II 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 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2209-2012
    Event ID
    62586
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 22, 2012
    Initiation Date
    February 1, 2012
    Classification Date
    August 15, 2012
    Termination Date
    July 16, 2013
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733, United States

    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

    Code Info

    Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.

    Distribution

    Nationwide Distribution (USA).

    Quantity

    2,132 boxes