BEUDAMED
    FDA Enforcement Class II Terminated

    Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

    Recall: Z-0998-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0998-2020
    Event ID
    84518
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    December 11, 2019
    Classification Date
    February 5, 2020
    Termination Date
    July 8, 2022
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

    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

    Code Info

    Lot Number:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-7

    Distribution

    Nationwide: Foreign: Austalia, India

    Quantity

    92,836 vials