Events

Recall of Dako Beta-2-Microglobulin PET 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 Elitechgroup Australia 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-00331-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00331-1
  • 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
    There is a stability issue with a single component of the kit, vial 1 beta-2-microglobulin immunoparticles. investigations have shown that a change in the ph value in the beta-2-microglobulin immunoparticles (vial 1) has occurred resulting in low or no signal for the 2 lowest standards in the calibration curve. the identified change in the ph value may affect the accuracy of beta-2-microglobulin values/results obtained, without any warnings from instruments. the beta-2-microglobulin values may be measured up to 20% higher for samples in the clinically elevated ranges.
  • Action
    ELITech Group is advising users to cease use of the affected lot and discard any remaining inventory. This action has been closed-out on 18/07/2016.

Device

Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD) Product code: K0052Lot Number: 20012249ARTG number: 200116
  • Manufacturer
    Elitechgroup Australia PTY LTD

Manufacturer

Elitechgroup Australia PTY LTD