Events

Rappel de Foetal Haemoglobin Monoclonal Antibody (HBF-1). 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-2017-RN-01414-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-15
  • 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-01414-1
  • 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 australia have received four (4) customer complaints worldwide on multiple lots pertaining to poor antibody detection whereby customers reported little to no antibody staining. in the complaints received, customers identified a reduction in the intensity of staining, unequal staining, and in some instances, may have observed a reduction or shift in the positive population peak for foetal haemoglobin. with the use of controls, the end user can identify a product deficiency before diagnostic samples are analysed. failure of the positive controls to perform as expected is a basis for discarding test results and repeating the test.There have been no reports of injuries as a result of this issue.
  • Action
    Life Technologies is advising users to inspect stock and discard any remaining units of the affected lot number. There is unaffected stock available.

Device

Foetal Haemoglobin Monoclonal Antibody (HBF-1). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Foetal Haemoglobin Monoclonal Antibody (HBF-1). An in vitro diagnostic medical device (IVD) Catalogue Number: MHFH01Lot Number: 1848553AExpiry date: 31 January 2019ARTG Number: 212744
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd