Events

Recall of QIAsymphony DSP Virus/Pathogen Midi Kit. An in vitro Diagnostic Medical Device (IVD)(DNA/RNA purification system)

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-2014-RN-01281-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01281-1
  • 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
    Some reagent cartridges (reag cart) of this kit lot contain reagent troughs that are not filled correctly. this leads to decreased quality of the resulting nucleic acids.
  • Action
    End users are advised to discard any remaining affected lots of QIAsymphony DSP Virus/Pathogen reagent. It is also recommend that results from samples processed on the QIAsymphony using the affected reagent are reviewed. This action has been closed-out on 15/07/2016.

Device

QIAsymphony DSP Virus/Pathogen Midi Kit. An in vitro Diagnostic Medical Device (IVD)(DNA/RNA puri...
  • Model / Serial
    QIAsymphony DSP Virus/Pathogen Midi Kit. An in vitro Diagnostic Medical Device (IVD)(DNA/RNA purification system)Lot Number: 148028163
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd