Events

Rappel de OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device.

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-2018-RN-00291-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-03
  • 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-2018-RN-00291-1
  • 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 the performance of antibiotic in thermoscientific oxoid ct1412b cpo30 cefpirome may decrease when stored over 2°c after 24 months. the product has a registered shelf life of 36 months. performance remains unaffected throughout shelf life when stored at -20°c to +2°c. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for cefpirome.
  • Action
    Thermo Fisher is advising customers to inspect stock for affected product and remove them from further use. Users should destroy/discard all current and unused stock of the affected batches.

Device

OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device.
  • Modèle / numéro de série
    OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device. Lot Numbers:1611705, 1693625ARTG Number: 208273Thermo Fisher Scientific Australia & New Zealand - Antimicrobial susceptibility testing IVDs
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand