BEUDAMED
    FDA Recall Terminated

    SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

    Recall: Z-0364-2011 · Initiated June 1, 2010

    Recall

    Recall Number
    Z-0364-2011
    Event Number
    56865
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 1, 2010
    Posted
    November 15, 2010
    Terminated
    July 16, 2012

    Description

    SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

    Reason

    Functionality issue: For clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. This could cause incorrect results to be populated to a patient record.

    Action

    Clients were notified via the proprietary communication software on 06/01/2010. The communication discussed the risk-to-health notification task, potential hazard, root cause, corrective action, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.

    Distribution

    Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.

    Quantity

    40