BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments

    Recall: Z-2173-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2173-2012
    Event ID
    62403
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    June 7, 2012
    Classification Date
    August 9, 2012
    Termination Date
    April 1, 2014
    Address
    500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, 19714-6101, United States

    Description

    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments

    Reason

    The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys

    Code Info

    Version VA11B and all previously released versions.

    Distribution

    USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.

    Quantity

    15