Events

Rappel de Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin. 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 & 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-01097-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-10
  • 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-01097-1
  • 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 technical investigation by oxoid limited, part of thermo fisher scientific, has confirmed that certain lots of oxoid antimicrobial susceptibility testing disc cefoxitin may contain discs that have insufficient concentration of antibiotic. it has been identified that the low concentration may impact on the performance of the disc against escherichia coli and neisseria gonorrhoeae quality control organisms resulting in lower than expected zones of inhibition. performance with the staphylococcus aureus qc organism is currently within specification.Continued use of this lot could result in quality control failures, delayed results or incorrect results reporting.
  • Action
    End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 22/08/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin. An in vitro diagnostic medical device ...
  • Modèle / numéro de série
    Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin. An in vitro diagnostic medical device (IVD) Product Code: FOX30 CT0119BLot Numbers: 1689092 & 1689093093ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand