Events

Rappel de Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Saraya 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-2017-RN-00139-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-27
  • 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-00139-1
  • 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
    During storage the acecide test strips may have been stored outside the manufacturer recommended 2-8°c for longer than 14 days. as a result, the shelf life of the test strips may be affected. use of test strips that have not been stored according to the recommended conditions may alert users to change the acecide solution more often than required.
  • Action
    Customers are advised to check their inventory, quarantine, and dispose of any acecide test strips within their control. They will be provided with replacement stock for any affected inventory. Customers are also advised to ensure that the test strips must be stored between 2-8°C and that the test strip be used only after being brought to room temperature. This action has been closed-out on 01/03/2018.

Device

Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER...
  • Modèle / numéro de série
    Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)All stock currently in the marketARTG number: 170540
  • Manufacturer
    Saraya Australia Pty Ltd

Manufacturer

Saraya Australia Pty Ltd