BEUDAMED
    FDA Enforcement Class II Ongoing

    Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001

    Recall: Z-2354-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2354-2021
    Event ID
    88362
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    July 28, 2021
    Classification Date
    August 26, 2021
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001

    Reason

    Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

    Code Info

    Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.

    Distribution

    Worldwide distribution - US Nationwide distribution.

    Quantity

    9,555,555 (US); 5,128,758 (OUS)