Events

Rappel de Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin, CT1644B

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-01185-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-03
  • 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-01185-1
  • 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
    An internal investigation has confirmed that oxoid antimicrobial susceptibility testing disc qd15 quinupristin / dalfopristin may contain a small number of discs that produce variable results. not all of the lot is affected, however, it has been identified that some discs may produce larger than expected or unexpected zones of inhibition.Continued use of this lot could result in quality control failures, delayed results or false susceptibility reporting.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units. Results issued with the above batch should be reviewed against case histories, other results and other relevant individual data.

Device

Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin, CT1644B

Manufacturer

Thermo Fisher Scientific Australia & New Zealand