Events

Recall of Perfect Pool 10x10ml, 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 Grifols 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-2013-RN-00592-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00592-1
  • 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
    Barcode labels of reagents are incomplete or unreadable as they appear scratched and will not read on automatic analysers.
  • Action
    Grifols is advising their customers that return of affected stock will be organised once the next scheduled batch of product is received.

Device

Perfect Pool 10x10ml, an in vitro diagnostic medical device (IVD)
  • Model / Serial
    Perfect Pool 10x10ml, an in vitro diagnostic medical device (IVD)Product code: 903631LLot number: 06071.74.2Expiry date: 15/07/2013ARTG number: 178738
  • Manufacturer
    Grifols Australia Pty Ltd

Manufacturer

Grifols Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Source
    DHTGA