Events

Rappel de Device Recall Lite DM (Lite Data Manager)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Horiba Instruments Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69847
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0856-2015
  • Date de mise en oeuvre de l'événement
    2014-11-19
  • Date de publication de l'événement
    2014-12-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131698
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical device data system - Product Code OUG
  • Cause
    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)
  • Modèle / numéro de série
    Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide within the U.S.
  • Description du dispositif
    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
  • Adresse du fabricant
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Société-mère du fabricant (2017)
    Horiba Ltd.
  • Source
    USFDA