Events

Rappel de Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - 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-2013-RN-00776-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-29
  • 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-00776-1
  • 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
    Cell marque cdx-2 is used to aid in the differentiation of colorectal adenocarcinoma and lung adenocarcinomas. the cdx-2 antibody typically stains the nuclei of colorectal carcinoma cells but not lung adenocarcinoma cells. abacus has advised that the cdx-2 antibody may exhibit a light sporadic, focal, nuclear staining in a limited number of lung adenocarcinomas such as those with enteric differentiation, and may demonstrate slightly stronger staining than other lots.
  • Action
    Abacus ALS is requesting users to destroy affected stock. Replacement units will be provided as soon as possible. The requirement for a review of patient results reported from this lot should be determined by the laboratory director.

Device

Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)Catalogue Numbers: CM235R-17 and CM235R-18Lot Number: 1221903
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd