BEUDAMED
    FDA Recall Terminated

    Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001

    Recall: Z-0997-2020 · Initiated December 11, 2019

    Recall

    Recall Number
    Z-0997-2020
    Event Number
    84518
    Firm
    Roche Diabetes Care, Inc.
    FEI Number
    3011393376
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 11, 2019
    Terminated
    July 8, 2022
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001

    Reason

    Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

    Action

    Roche Diabetes Care issued Urgent Medical Device Corrections via UPS Ground mail to the patients and distributors on 12/11/2019. Letter states reason for recall, health risk and action to take: Immediately discontinue using test strip lots 497864 and 498315. Affected test strips must be discarded. To get replacement test strips, or for questions regarding this notification, use one of the following options: For fastest replacement of your product, please submit your request at https://notices.accu-chek.com. Email Accu-Chek Customer Care at [email protected] and include the following information: your name, full mailing address, phone number, test strip lot number and number of affected test strip vials. o Contact our Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. If a Business Reply Form was included with this notification, please complete and return it by U.S. mail using the provided postage paid envelope. Please keep this notification for future reference. Distributors/Suppliers instructed as follows: Discontinue distribution and destroy any remaining stock of the affected lots (497864 and 498315) immediately. make this notification available to consumer customers to whom you distributed affected product. If you have distributed affected product to other suppliers, provide a copy of this UMDC to those suppliers. Have those customers report the quantity of product destroyed to you.

    Distribution

    Nationwide: Foreign: Austalia, India

    Quantity

    82,332 vials