BEUDAMED
    FDA Enforcement Class II Terminated

    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.

    Recall: Z-0433-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0433-2014
    Event ID
    65147
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2013
    Initiation Date
    May 10, 2013
    Classification Date
    December 3, 2013
    Termination Date
    August 26, 2014
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.

    Reason

    Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System 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

    Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)

    Distribution

    Worldwide Distribution: USA (nationwide) and internationally to Canada.

    Quantity

    262