Events

Rappel de cobas p 612 pre-analytical system (LCP1). 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 Roche Diagnostics Australia Pty Limited.

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-2018-RN-00945-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-07-09
  • 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-2018-RN-00945-1
  • 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
    During internal investigations, roche diagnostics confirmed that in rare cases, sample material may come in contact with the pipetting nozzle during operation of the cobas p 612 pre-analytical system. this may lead to contamination of samples and, if a highly sensitive analytical technology is used e.G. molecular testing, inaccurate results may be produced.Cobas p 612 pre-analytical systems that use disposable filter tips are not affected by this issue.Roche has received no complaints worldwide for this issue; none from australian customers to date.
  • Action
    Roche Diagnostics Australia is advising that the use of disposable filter tips in the cobas p 612 pre-analytical system will be mandatory until the root cause is identified and appropriate corrective actions have been implemented. Roche Diagnostics Australia will contact laboratories in due course to arrange the modifications required for using disposable filter tips. The root cause investigation is still ongoing. Roche will send an update as soon as the root cause is identified and corrective measures are available.

Device

cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).Affected part: ADP NozzleMaterial Number: 07563116001ARTG Number: 212706(Roche Diagnostics Australia Pty Limited - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited