BEUDAMED
    FDA Enforcement Class II Terminated

    ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

    Recall: Z-0685-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0685-2020
    Event ID
    84231
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymer Technology Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2019
    Initiation Date
    December 2, 2016
    Classification Date
    December 13, 2019
    Termination Date
    July 16, 2020
    Address
    4600 Anson Blvd, Whitestown, IN, 46075, United States

    Description

    ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

    Reason

    A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.

    Code Info

    Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163

    Distribution

    The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico. The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay.

    Quantity

    20,825