Events

Recall of Anti-dsDNA Kit. 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 Immuno 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-01362-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01362-1
  • 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
    Specific product codes for the anti-dsdna kit (used to test for antibodies to dsdna), were omitted in error from the packaging material. customers have received the correct products, however due to the omission of the product code on the outer box it is not clearly identifiable if they have received the 50 tests version (im77 lot c323026) or 100 tests version (im771 lot c323027). the kits can be differentiated by the lot numbers printed on the outer box. please note that the individual component labelling within the kit has not been affected.The tracer and ammonium sulphate solution lot numbers were omitted for these particular lots of product listed above.
  • Action
    A set of labels (stickers) will be provided to customers to place over the existing directions that will correct the problem. The Customer Letter contains detailed instructions on where to place the stickers – including examples in the form of pictures. This action has been closed-out on 02/03/2016.

Device

Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD).50 Test kit Batch Number:- C323026 Product Code IM77100 Test kit Batch Number:- C323027 Product Code IM771
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA