Events

Rappel de PregSure Digital Pregnancy Test & Pregsure 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 Genesis Biotech 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-00230-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-27
  • 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-00230-1
  • 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
    Genesis biotech pty ltd has been advised that testing by thetga has identified that two batches of pregsure digital pregnancy test strips and pregsure pregnancy test strips were not sensitive to hcg at 25 miu/ml. consequently, these batches are being recalled.
  • Action
    Pharmacies are to inspect stocks and quarantine all units from the affected batches. Genesis Biotech will arrange for the quarantined stock to be recovered and replacement stock or a credit note to be issued.

Device

PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device ...
  • Modèle / numéro de série
    PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device (IVD).PregSure Digital Pregnancy TestCatalogue Number: LS-620Batch Number: 16D119-1100PregSure Pregnancy Test (midstream)Catalogue Number: LS-633Batch Number: 16D119-0000ARTG Number: 236402
  • Manufacturer
    Genesis Biotech Pty Ltd

Manufacturer

Genesis Biotech Pty Ltd