Events

Rappel de One Step HCG Urine Pregnancy 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 Murray International Trading 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-00024-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-08
  • 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-00024-2
  • 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
    Subsequent to complaints regarding false negative results by the users, results of the testing undertaken by the tga for the above batches have showed that these batches do not comply with the claim in the instructions for use which specify that “in less than 5 minutes, levels of hcg as low as 25miu/ml can be detected”. batch # 20150314 has failed to detect hcg in human urine at concentrations of 10, 25, and 50 miu/ml levels while batch # 20140406 has failed at hcg concentrations of 10, 25, 50 and 100 miu/ml . the tga is undertaking further investigation to ascertain if any further actions are required.False negative results in the worst case can result in misdiagnosis and significant harm.
  • Action
    Customers are advised to quarantine any unused stock from the above batches and return it to Murray International Trading Pty Ltd.

Device

One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD)Batch Numbers: 20140406 and 20150314ARTG number: 260088
  • Manufacturer
    Murray International Trading Pty Ltd

Manufacturer

Murray International Trading Pty Ltd
  • Source
    DHTGA