BEUDAMED
    FDA Enforcement Class II Terminated

    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher

    Recall: Z-3187-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3187-2018
    Event ID
    80672
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tecan US, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    July 23, 2018
    Classification Date
    September 18, 2018
    Termination Date
    August 26, 2020
    Address
    9401 Globe Center Dr Ste 140, N/A, Morrisville, NC, 27560-6211, United States

    Description

    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher

    Reason

    There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sample Tracking -Multi Instrument V1.0 or higher, Part Number 30019971.

    Code Info

    Part Numbers for Models of Freedom EVO with any version of EVOware: a. Freedom EVO 100: 10641100, 30020010, 30032010; b. Freedom EVO 150: 10641150, 10641152, 30020015, 30032015; c. Freedom EVO 200 Base Unit: 10641200, 10641202, 30020020, 30032020; Part Numbers for Software: EVOware Sample Tracking Add-On for Multi¿ Instrument Configurations: 30019971; Serial Numbers for device: 1302001540, 1708006808, 1208007284, 1503007126, 1503007304, 905000588, 1205002755, 1205002802, 1305007607, 1308005431, 1310005144, 1310005145, 905000587, 1705007973, 904000335, 1510009082, 1109004352, 1704005194, 1007000504, 1305002594, 1307006551 and 1105004439.

    Distribution

    Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.

    Quantity

    19 EVOware Sample Tracking Software Add-on