Events

Rappel de cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific 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-2014-RN-01201-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-11
  • 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-2014-RN-01201-1
  • 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
    Radiometer has become aware that the ccrea results for qc decreases to below the lower acceptance limit within the lifetime of the crea membranes. this has been experienced on membranes down to five days after installation of new membrane units.
  • Action
    Radiometer is advising their customers to perform one quality control measurement using S7835 AutoCheck 6+, level 1 (Item 944-094), on already installed Crea membrane units to verify the cCrea performance. If the QC result is out of range, please install new Crea A and Crea B membranes. Until further notice the following must be carried out every 24 hours: - Perform one quality control measurement using S7835 AutoCheck 6+, level 1 (944-094) to verify the cCrea performance. - If the QC result is out of range, new Crea A and Crea B membranes must be installed. This action has been closed-out on 05/08/2016.

Device

cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range
  • Modèle / numéro de série
    cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range Item Number: 942-073ARTG Number: 229300
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd