Events

Rappel de Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml

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 & New Zealand.

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-2015-RN-01024-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-23
  • 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-2015-RN-01024-1
  • 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
    A technical investigation has confirmed that the affected lot contains insufficient concentration of penicillin. continued use of this product could result in the incorrect reporting of minimum inhibitory concentration against penicillin.
  • Action
    Thermo Fisher is advising users to inspect stocks and remove from use any remaining units of the affected lot number. Affected stock can be returned or destroyed for credit. Results issued with the affected lot number should be reviewed against case histories, other results and other relevant individual data. This action has been closed-out on 25/08/2016.

Device

Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml

Manufacturer

Thermo Fisher Scientific Australia & New Zealand