Events

Recall of FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). 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 Diagnostic Solutions 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-01184-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01184-1
  • 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
    Diagnostic solutions has been informed by the manufacturer that there is an issue with the stability of the calibrator in the kit. an increase of fluorescence was observed during the ageing of the calibrator and therefore a decrease in patient results.
  • Action
    Diagnostic Solutions to advising users to inspect stock and destroy any remaining kits of the affected lots. Affected stock will be replaced with unaffected product. It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 11/05/2017.

Device

FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An ...
  • Model / Serial
    FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)Product Code: BM-MX005-sLot Number: LE124535Expiry: 31 Jan 2018ARTG Number: 198370
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd