Events

Rappel de Accu-Chek Inform II 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-00417-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-07
  • 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-00417-1
  • 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 has identified a certain test strip lot that potentially shows an increase in strip errors prior to dosing. due to the designed fail-safe in the blood glucose meter, the issue can be identified by the error message displayed on the meter upon strip insertion or through the device not recognising the test strip, respectively. however, in a limited number of cases the test strip can produce a biased result i.E. a false high or low value, which might not be detected easily and which could lead to erroneous therapy adaptations.
  • Action
    Roche is advising customers to identify affected lot numbers from inventory. If impacted stock is identified users should discontinue using strips immediately and discard. Users should use an alternate unaffected lot to monitor patients' glucose levels.

Device

Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)Material Number: 05942861022Lot: Number: 476639ARTG Number: 286479(Roche Diagnostics Australia - Clinical chemistry substrate IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited