BEUDAMED
    FDA Enforcement Class II Terminated

    FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810

    Recall: Z-1558-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1558-2020
    Event ID
    84866
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    November 14, 2019
    Classification Date
    March 23, 2020
    Termination Date
    April 28, 2021
    Address
    1360 S Loop Rd, N/A, Alameda, CA, 94502-7000, United States

    Description

    FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810

    Reason

    Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.

    Code Info

    All lots.

    Distribution

    U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN

    Quantity

    N/A