Events

Rappel de Combur10 Test UX when measured on Urisys 1100. 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-00349-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-09
  • 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-00349-1
  • 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 changed the performance claims for the combur10 test ux when measured on the urisys 1100 analyser.Roche performed internal performance studies, in order to maintain products’ compliance to current regulatory requirements. these studies determined that the limit of detection (lod) of certain parameters when measured on the urisys 1100 analyser varied from the claims stated in the ifu current at the time of testing.Parameters with changed lod are: protein, nitrite, ketone bodies, leukocytes, and blood: intact erythrocytes. note:values for all other parameters measured by the combur10 test ux remain unchanged.The lower lod for visual reading remains unchanged for all parameters.Roche has received no customer complaints worldwide in relation to this issue.
  • Action
    Roche is advising users to verify negative results for Protein, Nitrite, Ketone bodies, Leukocytes or Blood (intact erythrocytes), by visual reading, using the colour scale provided on the test strip vial. In case of discrepant values, the visually determined value shall be reported.

Device

Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)Material Number: 11544373049 (100 tests)All Lots lower than 29896103ARTG Numbers: 224003 (Roche Diagnostics Australia - Clinical chemistry biological screening IVDs) 212706 (Roche Diagnostics Australia - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited