Events

Recall of Device Recall Lite DM (Lite Data Manager)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Horiba Instruments Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69847
  • Event Risk Class
    Class 2
  • Event Number
    Z-0856-2015
  • Event Initiated Date
    2014-11-19
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131698
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Medical device data system - Product Code OUG
  • 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.
  • Action
    ACTION/RESOLUTION: Before accepting any results please verify the Sample ID in the Worklist matches the Sample ID of the Patient information displayed for the results (Figure 1 below). If the two numbers do not match please contact HORIBA Medical Technical Support. Your Lite DM should be upgraded to V3.0.0.21. Please contact HORIBA Medical Technical Support to schedule an upgrade. Please call the following phone # 1(888) 903-5001 prompt # 3. Please share this information with your laboratory staff and retain this notification as part of your laboratory documentation. It is mandatory for you to complete and return the enclosed response form within 10 days, in order for us to verify your understanding of this Field Information Notice. If you have any questions or concerns, please contact your local HORIBA Medical representative. We sincerely apologize for any inconvenience this may cause your laboratory.

Device

Device Recall Lite DM (Lite Data Manager)
  • Model / Serial
    Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide within the U.S.
  • Product 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.
  • Manufacturer
    Horiba Instruments Inc

Manufacturer

Horiba Instruments Inc
  • Manufacturer Address
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Manufacturer Parent Company (2017)
    Horiba Ltd.
  • Source
    USFDA