BEUDAMED
    FDA Enforcement Class II Terminated

    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device 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-2305-2012 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2305-2012
    Event ID
    62709
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2012
    Initiation Date
    May 29, 2012
    Classification Date
    August 31, 2012
    Termination Date
    April 10, 2014
    Address
    500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, 19714-6101, United States

    Description

    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device 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

    When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte

    Code Info

    Version VA11B and all previously released versions.

    Distribution

    USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.

    Quantity

    44