Events

Rappel de Red top histology jars containing 10% Neutral Buffered Formalin Solution. 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 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-2016-RN-01108-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-08-22
  • 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-2016-RN-01108-1
  • 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
    Investigations by thermo fisher scientific have confirmed that an error in jar labelling has occurred in certain lots of red top histology jars (with formalin) for tissue specimens. correct label:“tissue specimen” “poison – contains 10% buffered formalin”incorrect label:“specimen container for urine, sputum, semen, etc” poison statement missing.
  • Action
    Thermo Fisher is advising users to inspect stock and return the affected stock for replacement with unaffected product. This action has been closed-out on 15/02/2017.

Device

Red top histology jars containing 10% Neutral Buffered Formalin Solution. An in vitro diagnostic ...
  • Modèle / numéro de série
    Red top histology jars containing 10% Neutral Buffered Formalin Solution. An in vitro diagnostic medical device (IVD)Code: FNNNBF/30CAPITALBatch Numbers: 1508201420, 1508201420, 1606220560ARTG Number: 243713
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd