BEUDAMED
    FDA Recall Terminated

    SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.

    Recall: Z-0344-2011 · Initiated February 16, 2010

    Recall

    Recall Number
    Z-0344-2011
    Event Number
    56863
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 16, 2010
    Posted
    November 10, 2010
    Terminated
    July 17, 2012
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    Description

    SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.

    Reason

    When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result.

    Action

    Clients were notified via the proprietary communication software on 02/16/2010. The Notification Verbiage identified the affected product and informed clients of the 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

    Nationwide Distribution - US and Puerto Rico.

    Quantity

    31