Events

Rappel de ACE Control. 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 Immuno 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-00156-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-14
  • 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-00156-1
  • 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
    Upon review of the qa release testing, the range calculated at the time of kit release (done per standard operating procedures) supports the control range assigned upon product release, i.E. 28-52 at 37°c. however, upon investigation of a complaint encompassing several lots of reagents, the assigned control range has been reevaluated and it was determined that the range for these lots requires an adjustment to 23-43 at 37°c.This recall action was carried out prior to approval of the recall strategy by the therapeutic goods administration.
  • Action
    Immuno provided updated product information with the correct control ranges.

Device

ACE Control. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ACE Control. An in vitro diagnostic medical device (IVD)Product Code: A6040Lot Numbers: 042, 043 and 044ARTG Number: 203619
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA