BEUDAMED
    FDA Enforcement Class II Terminated

    Paragon Laboratory Management

    Recall: Z-2263-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2263-2015
    Event ID
    71570
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    McKesson Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    June 15, 2014
    Classification Date
    July 27, 2015
    Termination Date
    February 1, 2022
    Address
    10735 David Taylor Dr Ste 100, N/A, Charlotte, NC, 28262-1288, United States

    Description

    Paragon Laboratory Management

    Reason

    For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the data.

    Code Info

    Model 12.1 and 12.1.1

    Distribution

    Nationwide Distribution including Puerto Rico and to the states of : CA, CO., CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OA, PA, SC, SD, TN, TX, VT, VA, WV and WY.

    Quantity

    128