Events

Rappel de Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical device.

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-2018-RN-00329-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-16
  • 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-2018-RN-00329-1
  • 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
    It has been identified that the primary labels of the affected vials of m0880 were mislabelled with an incorrect concentration. the concentration was written to be 187 mg/l. the correct concentration is 485 mg/l.To date, no customer complaints have been received as a result of this issue.
  • Action
    Agilent Technologies is advising customers to discard any bottles of the affected lots of this product in line with the precautions outlined in the IFU. Agilent will provide replacement product to affected sites who hold unused or partially used vials. Agilent Technologies is advising users who may have run results at an altered dilution due to the larger protein concentration and without appropriate run controls to review results and re-run where required.

Device

Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical de...
  • Modèle / numéro de série
    Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical device.Code Number: M0880 Lot Numbers: 20033445 and 20042272ARTG Number:183436(Agilent Technologies Australia - Immunohistology cell marker IVDs)
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd