Events

Rappel de SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA)

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-01176-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-11-28
  • 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-01176-1
  • 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
    Fertipro has informed that some customers have reported reduced motility in certain semen samples when using the updated spermmar iga test (brown beads). this reduced motility may result in a lower proportion of free moving sperm and affect the interpretation of the results.
  • Action
    Customers are instructed to stop using and destroy the affected batches. Fertipro is currently working on optimising the buffer of the reagent to avoid this reduction in motility. The optimised reagent will be included from batch FP14A11 onwards. Users are advised that the need for a look back at previously reported results be discussed with their clinical/laboratory director. This action has been closed-out on 01/03/2016.

Device

SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA)
  • Modèle / numéro de série
    SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA) BatchNumber: FP14A09, FP14A10An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA