Events

Rappel de enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06

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-2014-RN-00414-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-07
  • 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-2014-RN-00414-1
  • 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
    The engen laboratory automation system is an automated track which integrates clinical analysers and the customer’s lis (laboratory information system). it centrally controls pre-analytical and post-analytical processing as well as sample transport to multiple independent analysers and devices. ortho clinical diagnostics (ocd) internal testing has determined that when a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (storage) prior to the completion of the necessary pending action. a delay in patient test result(s) reporting could occur.
  • Action
    Laboratories are advised to manually rerun samples that have been prematurely stored. A software modification is currently in development and will be provided once complete. This action has been closed-out on 11/02/2016.

Device

enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) ...
  • Modèle / numéro de série
    enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06Product Code: 6802883Lot Numbers: enGen Select Versions 3.2.2 and below & enGen Custom versions 3.2.2 and below
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics