Events

Recall of ALBAclone Advanced Partial RhD Typing Kit. 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 Haemokinesis 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-2017-RN-00628-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00628-1
  • 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
    The manufacturer has found that lot no v174693 has a reduced level of performance associated with components h and l, which are generating weaker than normal reactions with some weak rhd and partial rhd samples. reduced reactivity of components h and l is considered to make interpretation of the rhd variant sample type more difficult given results are available from only ten of the twelve monoclonal anti-d cell lines contained in the kit.
  • Action
    Haemokinesis is advising users to quarantine and dispose of the affected lots. Haemokinesis will provide replacement stock or will issue a credit note. For previously generated results, the laboratory Medical Director should take into consideration the possible reduced reactivity of component H and L.

Device

ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: Z293Lot Number: V174693Expiry Date: 13 July 2017ARTG Number: 225063
  • Manufacturer
    Haemokinesis Pty Ltd

Manufacturer

Haemokinesis Pty Ltd