Events

Rappel de enGen Laboratory Automation Systems, 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-2015-RN-00328-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-13
  • 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-2015-RN-00328-1
  • 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 (ocd) is advising users of a software anomaly regarding the routing of urine samples which required pre-treatment for assays using vitros chemistry products ca, mg and phos slides. the engen system software currently does not route samples which require acidification pre-treatment to the manual high priority exit location for pre-treatments as intended. in addition, the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pre-treatment. ocd internal testing has confirmed instances where vitros 5,1 fs, 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen, regardless of the pre-treatment requirements for each selected assay, potentially leading to biased patient results.
  • Action
    OCD is providing temporary work around instructions for users to prevent the failure mode. A software update will be implemented as a permanent fix. Also, OCD is advising users to discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 11/08/2016.

Device

enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)Affected Versions: Systems configured with enGen Select v5.0 and Custom or Select v3.2.2 and belowProduct Code: ENGEN
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics