Events

Recall of G-6-PDH Control Kits, Normal. 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-2013-RN-00369-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00369-1
  • 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
    Following an investigation of customer complaints, the affected lot numbers have been found to have poor stability following reconstitution. it has been confirmed that the reconstituted control does not maintain the full 7 day stability when stored at 2-8degc as stated in the package insert. the control may recover within range on day 1 after reconstitution, but will fall out of range before reaching 7 days.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Action
    Immuno is advising users to discontinue use of the affected lots, and destroy remaining stock. Affected stock will be replaced by Immuno.

Device

G-6-PDH Control Kits, Normal. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    G-6-PDH Control Kits, Normal. An in vitro diagnostic medical device (IVD)Product Code: G6888Lot Numbers: 035, 036, 037 & 038Expiration Date: 2013-12
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA