Events

Rappel de cobas 4800 HPV Amplification/Detection Kit. 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-2017-RN-00625-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-05-15
  • 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-00625-1
  • 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
    Through routine quality stability monitoring, roche has been made aware that certain lots of the cobas 4800 hpv amplification/detection kit are generating an increase in the frequency of invalid positive control (pc) results, causing the entire run to be invalidated on the cobas 4800 system. as a precautionary measure, roche has additionally temporarily shortened expiration dates for other selected lots of these kits to reduce the potential for invalid pc result generation.
  • Action
    Roche Diagnostics is requesting users with affected lots (as reflected in Table 1 of the recall notification) to immediately discontinue use of and discard the indicated lots. Users with affected lots (as reflected in Table 2) are advised to be aware of and adhere to the revised expiry date of the indicated lots. (Users are to note that the cobas 4800 System will not recognise nor flag the revised expiry of the affected kits. Therefore, close attention must be paid to the expiry dates listed in Table 2 and appropriate action taken accordingly.) Users will be assisted with the process of supply of replacement kits.

Device

cobas 4800 HPV Amplification/Detection Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    cobas 4800 HPV Amplification/Detection Kit. An in vitro diagnostic medical device (IVD)Material Numbers: 05235910190 and 05235901190Pack Size: 960 and 240 tests (respectively)Multiple Lot NumbersARTG Number: 187190
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited