Events

Rappel de Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit used for determination of G-6-PDH in blood)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Immuno Pty Ltd.

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-00081-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-31
  • 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-00081-1
  • 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 manufacturer, trinity biotech, has identified a potential for misdiagnosis with lot f117009. an investigation identified that this lot displays a level of accuracy variation outside the historical qc product release process control charts for normal range controls, despite falling within the qc acceptance specification. investigation testing has shown that there is objective evidence that the accuracy issue affects the normal patient range and not the deficient range with a potential health hazard of a false positive result (normal patient diagnosed as deficient) or an invalid test result occurring.
  • Action
    Immuno is advising customers to immediately discontinue use of the affected lot and destroy any remaining product. Laboratories are to consider the need to review results previously generated with the affected lot. Immuno will organise replacement kits.

Device

Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit ...
  • Modèle / numéro de série
    Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit used for determination of G-6-PDH in blood)Product Code: 345ALot Number: F117009Expiry: 4 April 2018ARTG Number: 203621
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA