Events

Recall of Quinn’s Advantage Medium with Hepes (In vitro fertilisation culture medium)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Origio Australasia 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-01552-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01552-1
  • 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
    Origio a/s has received two complaints regarding what appear to be particles, objects or growth in two bottles of the media. the media showed evidence of particulate matter, cloudiness, and was mis-coloured. to eliminate the risk of microbial contamination, art-1023, lot number 16280126 is being recalled.
  • Action
    Origio is advising users to return unused affected product. Origio will provide either replacement stock or issue credit for returned unused stock. This action has been closed-out on 09/06/2017.

Device

Quinn’s Advantage Medium with Hepes (In vitro fertilisation culture medium)
  • Model / Serial
    Quinn’s Advantage Medium with Hepes (In vitro fertilisation culture medium)Product Code: ART-1023Lot Number: 16280126Expiry Date: 14 July 2017ARTG Number: 151263
  • Manufacturer
    Origio Australasia Pty Ltd

Manufacturer

Origio Australasia Pty Ltd
  • Source
    DHTGA