Events

Rappel de cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)(for use on the cobas 6800/8800 systems)

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-2017-RN-00744-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-06-08
  • 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-2017-RN-00744-1
  • 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
    Roche diagnostics has observed an increased rate of invalid internal control (ic) results for cobas mpx when used with certain lots of the cobas omni mgp reagent. this issue affects only the blood screening assays, cobas mpx. for the non-blood screening assays, these lots of cobas omni mgp reagent continue to meet specifications, and no performance issues have been identified. the cobas 6800/8800 systems will correctly flag a sample result as invalid if the internal control is invalid. there is no risk of generating incorrect patient results as a consequence of this issue. all previously generated valid results and runs remain valid.
  • Action
    Roche is advising customers to restrict the use of affected cobas omni MGP Reagent lots to non-blood screening assays only (CMV; CT/NG; HPV), and discontinue the use of these specific lots with the cobas MPX.

Device

cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD...
  • Modèle / numéro de série
    cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)(for use on the cobas 6800/8800 systems)cobas omni MGP Reagent Material Number: 06997546190Pack Size: 480 testsLot Numbers: W17311, X05638, X05639, X16159ARTG Number: 175163
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited