Events

Rappel de Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) 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-2015-RN-01239-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-17
  • 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-2015-RN-01239-1
  • 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
    The internal investigation detected deviations in uric acid results on the reflotron system which can be above the internal specification of 5%, if the haematocrit values in whole blood samples exceed 48%. this may lead to erroneously low uric acid results in such blood samples. roche diagnostics are updating the product insert to include the revised limit.
  • Action
    Roche Diagnostics is advising users to note the haematocrit value limit has been reduced to a maximum of 48%, and advises users to take this into account when measuring patient samples from whole blood. Roche Diagnostics will be updating the Product Insert as a permanent correction.

Device

Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) A...
  • Modèle / numéro de série
    Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD)Material Number: 10745103202All lot numbers affectedARTG number: 174909
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited