Events

Rappel de artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trachomatis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Qiagen 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-01117-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-16
  • 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-01117-1
  • 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
    The artus c. trachomatis plus kits are designed to detect a 106 bp region of the chlamydia trachomatis chromosome and a 111 pb region of the crypticplasmid of c. trachomatis; however, the kits fail to detect the chromosomal target. the kits do not detect cryptic-plasmid-free variants.Accordingly, qiagen will be amending the instructions for use of this product to remove the claim that the product can detect cryptic-plasmid free variants of c. trachomatis.
  • Action
    QIAGEN is advising users to be aware that cryptic-plasmid-free variants of C. trachomatis are not detected by the kits. QIAGEN is advising a review of negative patient results is at the discretion of the Laboratory Manager. This action has been closed-out on 24/08/2016.

Device

artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trac...
  • Modèle / numéro de série
    artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trachomatis)artus C. trachomatis Plus RG PCR Kit (24) CE - Cat. No. 4559263artus C. trachomatis Plus RG PCR Kit (96) CE - Cat. No. 4559265artus C. trachomatis Plus LC PCR Kit (24) CE - Cat. No. 4559063artus C. trachomatis Plus LC PCR Kit (96) CE - Cat. No. 4559065artus C. trach. PLUS RG PCR Kit (768) CE - Cat. No. 4559267An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd