Events

Rappel de Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. 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 Life Technologies 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-2018-RN-00125-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • 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-2018-RN-00125-1
  • 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
    Life technologies has become aware of a performance issue where the specific lots of foetal haemoglobin monoclonal antibody are displaying high or unusually bright background which could potentially lead to erroneous(false positive) results.
  • Action
    Life Technologies is advising users to discard any remaining product of the affected lot. A product hold has been placed on future stock, and a credit will be provided for all affected stock. A review of previously generated test results should be performed at the discretion of the laboratory Director.

Device

Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD)Catalogue Number: MHFH01Lot Number: 1626670DExpiry Date: 30/04/2018ARTG Number: 212744 - (Life Technologies Australia - Haemoglobin IVD)
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd