Events

Rappel de Thermo Scientific MAS Omni-IMMUNE PRO. 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 Thermo Fisher Scientific.

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-00024-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-15
  • 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-00024-1
  • 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
    The constituent, inhibin a, was removed for mas omni-immune and mas omni-immune pro controls; however the package insert was not updated to reflect removal. the affected lots should not be used as control material for monitoring inhibin a assays. no other analytes of the mas omni-immune and mas omni-immune pro controls are affected.This action was undertaken prior to approval of the recall strategy by the tga.
  • Action
    Thermo Fisher Scientific is advising users to destroy any remaining stock of the affected lot numbers. An alternative product is available for use by affected users.

Device

Thermo Scientific MAS Omni-IMMUNE PRO. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Thermo Scientific MAS Omni-IMMUNE PRO. An in vitro diagnostic medical device (IVD) Catalogue Numbers: OPRO-101, OPRO-202, OPRO-303, OPRO -SPLot Numbers: OPRO15101, OPRO15102, OPRO15103, OPRO1510S
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific