Events

Recall of ENA RELISA Single Well Screen (576 well) 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 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-2015-RN-01194-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01194-1
  • 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 immuno concepts that incorrect calibrator has been included with affected lots of the ena relisa single well screen kits. this may result in over-sensitivity and false positive patient results.
  • Action
    Diagnostic Solutions is advising users to inspect stock and destroy any remaining kits of the affected lots. Diagnostic Solutions is recommending that a review of previously reported results is performed at the discretion of the Laboratory Director. This action has been closed-out on 25/08/2016.

Device

ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD) Product Code: IC7696-10Lot Numbers:1525909 and 1525812 ARTG Number: 197980
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd