Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Qiagen Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01117-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01117-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / 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