Events

Rappel de Glucose GLUC-PAP. 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 Randox Australia 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-2016-RN-01642-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-23
  • 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-2016-RN-01642-1
  • 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
    Randox confirms a transcription error when quoting the concentration in g/l for glucose standard lot 2082gl. the correct value should state 0.98g/l.The risk to health when this issue occurs is the potential for reporting incorrect elevated glucose results. however this is highly unlikely as quality control results would also be elevated by a factor of ten.
  • Action
    Randox is requesting users; 1. Replace the kit IFU with the correct revision as attached to the customer letter; 2. Discuss the contents of the notice with your Medical Director; and 3. Complete and return the vigilance response form provided.

Device

Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD).Catalogue Number: GL1021GTIN: 05055273203165Batch/Lot Number: 385671Expiry Date: 28th Jan 2019ARTG Number: 199617
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA