BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.

    Recall: Z-2561-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2561-2014
    Event ID
    68965
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    August 13, 2013
    Classification Date
    September 1, 2014
    Termination Date
    December 2, 2014
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.

    Reason

    May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

    Code Info

    EasyLink Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219

    Distribution

    US Nationwide Distribution

    Quantity

    1347