Events

Rappel de Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Conceiveplease 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-00190-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-23
  • 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-00190-1
  • 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 testing undertaken by the tga for the above batch of conceiveplease one step hcg urine pregnancy test has shown that this batch does not comply with the claim in the instructions for use which specify that "ln less than 5 minutes, levels of hcg as low as 25mlu/ml can be detected".Batch 20131203 failed to detect hcg in human urine at concentrations of 10 and 25miu/ml levels. false negative results in the worst case can result in misdiagnosis, which can have significant consequences. the tga is undertaking further investigations to ascertain if any further actions are required.
  • Action
    Please note that ConceivePlease Pty Ltd has advised the TGA that only fewer than 100 kits from the affected batch were supplied to retailers during a three week period, from 21 January to 11 February 2016. Customers are advised to quarantine any unused stock from the affected batch and return them to the place of purchase for a refund. For more information please see http://www.tga.gov.au/alert/conceiveplease-one-step-hcg-urine-pregnancy-test . This action has been closed-out on 19/01/2017.

Device

Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)
  • Modèle / numéro de série
    Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)Batch Number: 20131203Expiry Date: 12 September 2016ARTG Number: 212074
  • Manufacturer
    Conceiveplease Pty Ltd

Manufacturer

Conceiveplease Pty Ltd
  • Source
    DHTGA