BEUDAMED
    FDA Recall Terminated

    EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act upon AST results.

    Recall: Z-1414-2017 · Initiated August 25, 2014

    Recall

    Recall Number
    Z-1414-2017
    Event Number
    76498
    Firm
    Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    August 25, 2014
    Posted
    February 27, 2017
    Terminated
    March 8, 2017
    Address
    Sparks, MD, 21152-9212

    Description

    EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act upon AST results.

    Reason

    The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism.

    Action

    Customers were initially contacted via phone calls and subsequently provided with a written communication. For questions contact BD Technical Services Department at 1-800-638-8663.

    Distribution

    15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors

    Quantity

    Qty Distr. to Field - 115