BEUDAMED
    FDA Enforcement Class II Terminated

    Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

    Recall: Z-2185-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2185-2018
    Event ID
    80018
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 7, 2018
    Classification Date
    June 14, 2018
    Termination Date
    January 16, 2020
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

    Reason

    The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.

    Code Info

    Lots 496947, 497291, 497296, 497325

    Distribution

    Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"

    Quantity

    295, 248