Events

Rappel de Human IgM kit for use on SPAPLUS

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par In Vitro Technologies Pty Ltd.

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-00916-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-07
  • 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-00916-1
  • 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 investigation by in vitro technologies investigations of specific lots of human igm kit for use on spaplus have identified that the calibration stability has decreased in comparison to historical released kits. users will be able to identify when the calibration is no longer valid, as control values will fall outside of the provided acceptable limits.
  • Action
    The Binding Site recommends the following: 1. Batch sample analysis, when possible; 2. Recalibrate the assay when QC results have deviated outside of the specified range; 3. Contact In Vitro Technologies for any further guidance or additional kit requirements; and 4. Complete the acknowledgement form supplied with the customer letter, even if you do not have any of the affected product, and return it by email to QRA@invitro.com.au

Device

Human IgM kit for use on SPAPLUS
  • Modèle / numéro de série
    Human IgM kit for use on SPAPLUSItem Number: TBSNK012SLot Numbers: 400872 and 407480ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd