Events

Rappel de Oxoid AST Disc - Ceftazidime CAZ10. 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-2017-RN-01190-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-13
  • 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-2017-RN-01190-1
  • 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, part of thermo fisher scientific, has confirmed that the concentration of antibiotic in thermoscientific oxoid caz10 ceftazidime, ct1629b (specific lots) may decrease over shelf life if not stored frozen. specifically, antibiotic degradation has been identified in product stored at 8°c between 2 and 3 years of shelf life. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for ceftazimide.
  • Action
    1. Users are to inspect stocks and remove from further use all units from the nominated batch number, then complete the supplied Facsimile Reply Form a for a credit note to be issued. 2. Complete the supplied facsimile Reply Form even if there is no remaining stock subject to recall, so as to reconcile this process.

Device

Oxoid AST Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Oxoid AST Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)Product Code: CT1629BLot Numbers: 1883326, 1849729, 1814258, 1786239, 1752930, 1728103, 1683346, 1646438, 1611709, 1571939, 1562018, and 1558378ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand