Events

Rappel de FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. 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 Agilent 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-01330-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-31
  • 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-01330-1
  • 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
    Agilent has determined that a specific lot of flex monoclonal rabbit anti-human estrogen receptor clone ep1 has shown weak non-specific nuclear and cytoplasmic / stomal staining in known negative samples. in this affected lot some, but not all, breast cancer samples will show weak false-positive staining in some nuclei. this could result in a false-positive result in patient tissue and may not be detected by run controls.To date, agilent has not received any customer complaints regarding this issue.
  • Action
    Agilent Technologies is advising users to discard affected Ready-to-Use GA084 vials from the affected lots. The vials should be discarded in accordance with the precautions in the Instructions For Use. Agilent will be providing affected users with replacement product in lieu of GA084. Laboratory Managers should review assay runs and patient results where the affected lots were used.

Device

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnost...
  • Modèle / numéro de série
    FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnostic medical device (IVD).Code Number: GA084Lot Number: 10125849Expiry: 31 March 2018ARTG Number: 183436 (Agilent Technologies Australia Pty Ltd - Immunohistology cell marker IVDs)
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd