Events

Recall of EliA SmDP Well

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abacus ALS 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-00013-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00013-2
  • 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
    There have been unusually high numbers of positive results with elia smdp well lots, which are not due to anti-sm antibodies.All equivocal and positive patient sample results measured with lots 0018 and 0019 are potentially incorrect and are thus considered to be invalid. a false positive result could lead to unnecessary treatment/procedures.There is no indication that negative results generated with elia smdp well lots 0018 and 0019 are affected.
  • Action
    This action has been closed out 08 Jun 2017.

Device

EliA SmDP Well
  • Model / Serial
    EliA SmDP WellPart Number: 14-562-01Lot Numbers: 0018 and 0019Expiry Dates 30 November 2016 and 31 March 2017ARTG Number: 229585
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd