Events

Rappel de Mums The One One Step hCG Urine Pregnancy Test

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

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-00244-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-04
  • 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-00244-1
  • 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
    Testing undertaken by the tga for the above batch of 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 10miu/ml or 25mlu/ml can be detected".Batch 20151106 failed to detect hcg in human urine at concentrations of 10miu/ml, and 25miu/ml and 50miu/ml levels.False negative results in the worst case can result in misdiagnosis, which can have significant consequences.
  • Action
    Customers are advised to quarantine any unused stock from the affected batch and contact Mums The One to arrange for the return of the affected stock and a refund. If you suspect that you may have used a Mums The One one step hCG pregnancy test from the affected batch, it is recommended that you retest with a different product.

Device

Mums The One One Step hCG Urine Pregnancy Test
  • Modèle / numéro de série
    Mums The One One Step hCG Urine Pregnancy TestBatch Number: 20151106 ARTG Number: 152301
  • Manufacturer
    Mums The One

Manufacturer

Mums The One
  • Source
    DHTGA