Events

Rappel de ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). 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 Abacus ALS 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-00978-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-25
  • 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-00978-1
  • 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
    Abacus are informing users regarding an issue regarding immunocap specific ige control h vial lot cyyac. precipitates have been identified in the affected vials and kit lots. if samples containing precipitates are used, an increased frequency of functional disturbances (error messages e.G. clot error etc.) is to be expected in the instruments. occurrence of precipitate in the control, such as in vial lot cyyac, could give an increased frequency of functional disturbances in the instruments. however, in-house studies undertaken by the manufacturer show no indication that the ige results would be affected by the precipitates.
  • Action
    Abacus is advising users to inspect stock and discard any remaining kits of the affected lots. Affected product will be replaced by unaffected lots. This action has been closed out on 13 Jun 2017

Device

ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro di...
  • Modèle / numéro de série
    ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro diagnostic medical device (IVD)Kit Article Number: 10-9530-01Kit Lot Numbers: JBWA, JEXGVial Lot Number: CYYACARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd