Events

Recall of QIAsymphony DSP DNA Mini Kits. An in vitro diagnostic medical device (IVD).

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-2016-RN-00814-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00814-1
  • 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) in this kit lot contain a reagent cartridge holder with an incorrect shape. one “fixing projection” between well 1 and the bead trough is significantly larger and protruding. this could lead to interrupted runs or incorrect sample processing.
  • Action
    QIAGEN is advising users to quarantine any remaining stocks of the affected product. Product will be inspected and replaced if affected. QIAGEN is recommending a review of previously generated results. This action has been closed-out on 20/02/2017.

Device

QIAsymphony DSP DNA Mini Kits. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    QIAsymphony DSP DNA Mini Kits. An in vitro diagnostic medical device (IVD).Catalogue number: 937236Lot number: 154023773Reagent cartridge lot number: 154022318 ARTG number: 211651
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd