Events

Recall of Grifols Australia AHG Cards

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Grifols Australia Pty Limited.

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
    15381
  • Event Initiated Date
    2013-09-20
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Grifols Australia Pty Limited, 5/80 Fairbank Road, Clayton South, VIC 3169, AUSTRALIA
  • Reason
    The manufacturer advises that some cards are incompletely sealed. in affected cards this will induce deterioration of the card presentation, resulting in some microwells showing evaporation of the supernatant. this phenomenon can be observed as either a reduction in the gel level or the appearance of cracked gel.
  • Action
    Product to be destroyed

Device

Grifols Australia AHG Cards
  • Model / Serial
    Model: Product Codes: 71300048, 71300504, 71301008, Affected: Lot Number: 13059.01, Expiry: 10/14
  • Manufacturer
    Grifols Australia Pty Limited

Manufacturer

Grifols Australia Pty Limited
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Source
    NZMMDSA