BEUDAMED
    FDA Recall Terminated

    AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001

    Recall: Z-0044-2020 · Initiated August 13, 2019

    Recall

    Recall Number
    Z-0044-2020
    Event Number
    83646
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 13, 2019
    Terminated
    June 30, 2022
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001

    Reason

    AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results

    Action

    Roche Diagnostics issued Urgent Medical Notification letter to Distributor (TP-00744) and end users( TP-00741) on 8/13/19. Letter identifies problem, health risk and Actions required per the UMDC: " Check to see if you have any of the affected lot number(s) of AssayTips/AssayCup Trays on your cobas e 801 module or in your laboratory stock. (See pictures for lot number locations on packaging.). " Stop using the affected lot number(s) of AssayTips/AssayCup Trays immediately. " Discard the affected lot number(s) of AssayTips/AssayCup Trays according to your local waste management guidelines. To receive replacement product, fill out the attached fax form and fax or email it according to the instructions on the form. 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

    Distribution

    Nationwide

    Quantity

    935 units