Events

Recall of OriGen Syringe DMSO (Used for Research Use Only)

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-2012-RN-01041-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01041-1
  • 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
    Pure dmso is reacting with syringe polymers and degrading during storage and dmso begins to show a light yellow color. purity has dropped from 99.9% to 99.6% after six months in storage.This recall action was not notified to the tga before it was initiated by diagnostic solutions pty ltd.
  • Action
    The sponsor is asking users to quarantine and remove affected product and is supplying an alternative syringe until a replacement is available.

Device

OriGen Syringe DMSO (Used for Research Use Only)
  • Model / Serial
    OriGen Syringe DMSO (Used for Research Use Only)Multiple part numbers and lot numbers affected
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd