Events

Rappel de Multiplate Analyser. 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 Haemoview Diagnostics.

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-00734-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-14
  • 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-00734-1
  • 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
    Roche identified that specific multiplate stirrer boards (replaced by another type 7.5 years ago) may develop an increasing stirring speed above specification. all channels are affected in the same way. too high stirrer speed may correlate with a falsely decreased recovery and therefore may lead to falsely low patient results. investigation has showed in maximum a reduced recovery of 80% (= bias -20%) and that the degree of decreased recovery depends on assay, with adp, trap, aspi more affected than col. although no testing was performed for the ristotest and adptest hs, similar low recovery of platelet function test results is assumed for these tests. in case of falsely low patient results due to falsely decreased recovery of platelet function tests (adptest, aspitest, traptest, coltest, ristotest adp hs test) the platelet function in diagnostic measures may be incorrectly interpreted as impaired.
  • Action
    A Haemoview Diagnostics representative will schedule the necessary repair measures with the user. Until then, the affected Multiplate Analyser must not be used for diagnostic purposes. A loan device will be provided.

Device

Multiplate Analyser. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Multiplate Analyser. An in vitro diagnostic medical device (IVD)Product Code: 06675069001Serial Number: 100365ARTG Number: 263172
  • Manufacturer
    Haemoview Diagnostics

Manufacturer

Haemoview Diagnostics