BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-3187-2018 · Initiated July 23, 2018

    Recall

    Recall Number
    Z-3187-2018
    Event Number
    80672
    Firm
    Tecan US, Inc.
    FEI Number
    1037985
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 23, 2018
    Terminated
    August 26, 2020
    Address
    9401 Globe Center Dr, Ste 140, Morrisville, NC, 27560-6211

    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.

    Action

    On July 23, 2018, Tecan sent Field Corrective Action Letters to their consignees advising them of the problem. Field corrections will be made in the near future.

    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