BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1763-2017 · Initiated March 1, 2017

    Recall

    Recall Number
    Z-1763-2017
    Event Number
    76628
    Firm
    Roche Diagnostics Corporation
    FEI Number
    1823260
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 1, 2017
    Posted
    March 23, 2017
    Terminated
    July 3, 2018
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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."

    Action

    Roche initiated a recall on 03/01/2017, notices were issued via UPS to customers and instructed customers to do the following: Roche is developing software version 03-01 to resolve this issue, and a Roche Representative will be contacting you in the near future to schedule an update. Until this software update is available, the rack buffering option for the BRF and URF modules must be disabled. If you are an authorized cobas 8100 automated workflow series operator, follow the steps outlined below to disable rack buffering. If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. If you have a major spill, set the affected module to offline and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " If you are an authorized cobas 8100 automated workflow series operator, follow the steps outlined in this Urgent Medical Device Correction (UMDC) to disable rack buffering. " If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. " Complete the attached faxback form and fax it to 1-888-345-0024. " File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

    Distribution

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

    Quantity

    45 Units