Events

Rappel de ORTHO VISION Analyzer for ORTHO BioVue Cassettes, software version 2.12.6 and below. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ortho-Clinical Diagnostics.

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
    RC-2016-RN-00201-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-03-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00201-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Ortho-clinical diagnostics (ortho) has identified an anomaly in ortho vision analyser software that may occur when either:1. an ocd field engineer performs a clean-up of the analyser database, or an operator of the vision analyser restores a database backup on the analyser, and 2. dilution trays have not been removed from the instrument prior to restarting the system.In this scenario, the analyser software cannot identify usage history of the wells of the dilution tray on the instrument, and reuse of wells may occur.For tests that involve dilution of patient red blood cells, the reuse of a dilution well can potentially lead to false positive or false negative results. to date, only false positive results have been observed during internal testing. there is a risk of false positive or false negative anti-d testing, which may result in haemolytic transfusion reaction. no customer complaints or patient injuries have been reported due to this issue.
  • Action
    Ortho Clinical is reminding users to ensure the dilution wells are removed and disposed of prior to initiating a database restore operation. This issue will be addressed in a future version of the software and a Technical Bulletin issued to remind users to remove and dispose of dilution wells prior to restoring a database. This action has been closed-out on 20/02/2017.

Device

ORTHO VISION Analyzer for ORTHO BioVue Cassettes, software version 2.12.6 and below. An in vitro ...
  • Modèle / numéro de série
    ORTHO VISION Analyzer for ORTHO BioVue Cassettes, software version 2.12.6 and below. An in vitro diagnostic medical device (IVD)Product Code: 6904579Software Version: 2.12.6 and belowARTG Number: 229946
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics