BEUDAMED
    FDA Recall Terminated

    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.

    Recall: Z-0083-2012 · Initiated May 11, 2009

    Recall

    Recall Number
    Z-0083-2012
    Event Number
    52105
    Firm
    Data Innovations, Inc.
    FEI Number
    3001451449
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 11, 2009
    Posted
    October 21, 2011
    Terminated
    October 25, 2011
    Address
    120 Kimball Ave, Ste 100, South Burlington, VT, 05403-6837

    Description

    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.

    Reason

    The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result".

    Action

    Data Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.

    Distribution

    USA (nationwide) and the country of Canada.

    Quantity

    188