Events

Recall of Grifols Australia AHG Cards. 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-00947-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00947-1
  • 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
    Grifols australia is undertaking a recall due to a potential finding of higher than expected number of cards with wells showing incorrect level of supernatant or cracked gel when they perform the intiial visual check of the cards as stated in the instructions for use. the origin of the problem is a production incident in the card sealing process where some cards were incorrectly sealed. this issue will induce supernatant evaporation that finally will lead to incorrect supernatant levels or cracked gel.
  • Action
    End users are requested to quarantine all stock from the affected lot and contact Grifols to arrange for replacement stock. Once replacement stock has been received end users are requested to discard the affected lot in their biological waste.

Device

Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)Item Codes: 71300048, 71300504 & 71301008Lot Number: 13059.01Expiration Date: 10/2014ARTG Number: 178738
  • Manufacturer
    Grifols Australia Pty Ltd

Manufacturer

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