BEUDAMED
    FDA Recall Terminated

    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

    Recall: Z-1090-2017 · Initiated December 27, 2016

    Recall

    Recall Number
    Z-1090-2017
    Event Number
    76078
    Firm
    Roche Diagnostics Corporation
    FEI Number
    1823260
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 27, 2016
    Posted
    January 24, 2017
    Terminated
    August 4, 2017
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

    Action

    On 12/27/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected Consignees via courier fax or email. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The cobas p 612 pre-analytical system (63x) software is being revised to correct the aspiration process. We anticipate this new version (2.0.4) to be available during Quarter 1 2017. For now, discontinue using disposable non-filter tips for Aliquotting on your cobas p 612 pre-analytical system (63x). You will be contacted by a Roche Field Engineering Specialist (FES) about modifying your system to allow for the use of disposable filter tips. Filter tips will be provided at the time of service. Actions Required " Immediately discontinue using disposable non-filter tips for Aliquotting on your cobas p 612 pre-analytical system (63x). " Complete the enclosed faxback form and fax it to number 1-877-906-8982 or email it to [email protected]. " Provide copies of this UMDC to other clinicians who may need to be aware of this software issue. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336, 24 hours a day/7 days a week, if you have questions about the information contained in this UMDC.

    Distribution

    TX and WA

    Quantity

    5