BEUDAMED
    FDA Enforcement Class II Terminated

    Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 Hematology Analyzer. Only one instrument connection is allowed per each Lite DM workstation. The Lite DM application runs on a PC within a Windows Operating System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS  Laboratory Information System or EMR  Electronic Medical Record system). Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.

    Recall: Z-0856-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0856-2015
    Event ID
    69847
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    November 19, 2014
    Classification Date
    December 23, 2014
    Termination Date
    June 22, 2015
    Address
    9755 Research Dr, Irvine, CA, 92618-4626, United States

    Description

    Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 Hematology Analyzer. Only one instrument connection is allowed per each Lite DM workstation. The Lite DM application runs on a PC within a Windows Operating System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS  Laboratory Information System or EMR  Electronic Medical Record system). Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.

    Reason

    HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is

    Code Info

    Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A

    Distribution

    Nationwide within the U.S.

    Quantity

    322 (5 in U.S. Military)