Events

Rappel de cobas MPX test. 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-00356-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-14
  • 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-00356-1
  • 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
    Globally, roche has received a number of customer reports of selected lots of the cobas mpx test generating unexpected initial false reactive results, which do not match the serology profile of the sample. roche diagnostics australia has received no reports of false reactive results with the affected lot numbers from australian customers.
  • Action
    Roche is requesting users to discontinue use of and discard any remaining inventory of the affected lots, on receipt of replacement unaffected stock. A Roche Diagnostics Australia representative will be in touch with any affected customers to arrange replacement stock.

Device

cobas MPX test. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    cobas MPX test. An in vitro diagnostic medical device (IVD). Material Number: 06997708190 (96 tests)Lot Numbers: 242567 and 267989ARTG Number: 275469Roche Diagnostics Australia - cobas MPX. - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited