BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1558-2020 · Initiated November 14, 2019

    Recall

    Recall Number
    Z-1558-2020
    Event Number
    84866
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    JIN
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    November 14, 2019
    Posted
    February 28, 2020
    Terminated
    April 28, 2021
    Address
    1360 S Loop Rd, Alameda, CA, 94502-7000

    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.

    Action

    On 11/14/19, Urgent Medical Device Correction notices were mailed to customers via overnight delivery. Customers were told to continue to use instructions for use regarding the cleaning of meters for use on single patients only. Customers were further asked to complete and return customer response forms. Customers with additional questions were encouraged to call customer service in 1-888-522-5226.

    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