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-2016-RN-01323-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-13
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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 shelf life of two lots of the albaclone advanced partial rhd typing kit has been reduced from 24 months to 12 months based on stability testing results for component l (anti-d cell line lhm57/17). the revised shelf life for each of these lots of kit has now expired and the kits are being recalled.
  • 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 L.

Device

  • Model / Serial
    ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD).Product Code: Z293Affected Lot Numbers:V163020, expiry 11 Aug 2017V157640, expiry 9 Mar 2017ARTG Number: 225063
  • Manufacturer

Manufacturer