Events

Recall of Grifols Australia Perfect Panel cells

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-2014-RN-01020-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01020-1
  • 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 wishes to advise of an error identified on the antigen composition sheet for perfect panel.The antigen composition sheet supplied with the affected lots of product states cell no. 6 as donor no.154. the antigen composition sheet should state cell no. 6 as donor no. 213 and the corresponding phenotypic profile.
  • Action
    Grifols Australia is providing their customers with the correct Antigen Composition Sheet with the recall action correspondence. This action has been closed-out on 06/06/2016.

Device

Grifols Australia Perfect Panel cells
  • Model / Serial
    Grifols Australia Perfect Panel cellsProduct Codes: 904114, 904125, 904114L, 904125L, 904114TSet Lot Numbers: 904114.04.2, 904125.04.2, 904114L.04.2, 904125L.04.2 and 904114T.73.1Expiry date: 17/11/2014ARTG number: 178738
  • Manufacturer
    Grifols Australia Pty Ltd

Manufacturer

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