BEUDAMED
    FDA Enforcement Class II Terminated

    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

    Recall: Z-1763-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1763-2017
    Event ID
    76628
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    March 1, 2017
    Classification Date
    April 8, 2017
    Termination Date
    July 3, 2018
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

    Reason

    "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over."

    Code Info

    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400

    Distribution

    Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None

    Quantity

    45 Units