Events

Retiro De Equipo (Recall) de artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trachomatis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Qiagen Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01117-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01117-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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