Events

Rappel de Grifols Australia AHG Cards. 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 Grifols 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-2013-RN-00947-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-09-13
  • 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-2013-RN-00947-1
  • 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
    Grifols australia is undertaking a recall due to a potential finding of higher than expected number of cards with wells showing incorrect level of supernatant or cracked gel when they perform the intiial visual check of the cards as stated in the instructions for use. the origin of the problem is a production incident in the card sealing process where some cards were incorrectly sealed. this issue will induce supernatant evaporation that finally will lead to incorrect supernatant levels or cracked gel.
  • Action
    End users are requested to quarantine all stock from the affected lot and contact Grifols to arrange for replacement stock. Once replacement stock has been received end users are requested to discard the affected lot in their biological waste.

Device

Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)Item Codes: 71300048, 71300504 & 71301008Lot Number: 13059.01Expiration Date: 10/2014ARTG Number: 178738
  • Manufacturer
    Grifols Australia Pty Ltd

Manufacturer

Grifols Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Grifols Sa
  • Source
    DHTGA