Events

Rappel de LIFECODES LifeScreen Deluxe (LMX). 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 Diagnostic Solutions 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-2015-RN-01026-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-10-20
  • 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-01026-1
  • 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
    During stability testing at test point 9 months, with lmx lot 3002350, immucor observed false positive results with a single sample. the sample is expected to test negative for both hla class i and class ii. the sample gave a qualitative result of ci (-), cii (+), indicating a false positive for hla class ii.
  • Action
    Diagnostic Solutions is advising users to destroy any remaining stocks of the affected lots. It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 19/08/2016.

Device

LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).Code Number: TL628215Lot Number: 3002350Expiration Date: 15 Nov 2015ARTG Number: 217870
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd