BEUDAMED
    FDA Recall Terminated

    Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)

    Recall: Z-0167-2007 · Initiated August 10, 2006

    Recall

    Recall Number
    Z-0167-2007
    Event Number
    36508
    Firm
    Data Innovations, Inc.
    FEI Number
    3001451449
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2006
    Posted
    November 14, 2006
    Terminated
    February 22, 2016
    Address
    120 Kimball Ave, Ste 100, South Burlington, VT, 05403-6837

    Description

    Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)

    Reason

    Patient results may be associated with an incorrect specimen

    Action

    Data Innovations notified customers by an email listserv notification and by letter dated 8/17/06. A patch would be available on the website to be downloaded.

    Distribution

    Worldwide distribution (USA and Canada)

    Quantity

    187