BEUDAMED
    FDA Enforcement Class II Terminated

    Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.

    Recall: Z-1851-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1851-2019
    Event ID
    82822
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tecan US, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2019
    Initiation Date
    April 12, 2019
    Classification Date
    June 21, 2019
    Termination Date
    January 18, 2022
    Address
    9401 Globe Center Dr Ste 140, N/A, Morrisville, NC, 27560-6211, United States

    Description

    Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.

    Reason

    Gas springs not always replaced within the interval specified.

    Code Info

    Freedom EVO 200 BASE UNIT 10641200 and 10641541 Freedom EVO 200 MCA96 BASE UNIT 30020020 Freedom EVO 200 MCA384 BASE UNIT 30032020 Freedom EVO 200-2 LiHa BASE UNIT 10641202 Serial Numbers 222, 702, 714, 506000013, 511000005, 603000004, 702000004, 703000002, 703000005, 703000006, 707001360, 710000367, 801002513, 801003121, 802003688, 805002719, 809002562, 810000017, 812002002, 906005647, 908002944, 910006632, 1004001243, 1006000274, 1006009336, 1009002730, 1011003146, 1011004081, 1011004086, 1011004089, 1011004095, 1104000151, 1108006349, 1108006724, 1108006777, 1109000886, 1109001036, 1109006938, 1111008689, and 1203005259.

    Distribution

    Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.

    Quantity

    40