Events

Recall of ALBAclone Anti-Leb, (LEB2) 1 x 5mL(Immunoglobulins capable of binding to specific red blood cell antigens and intended to be used in immunohaematological testing to provide information about red blood cell antigen phenotypes.)

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-2015-RN-00898-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00898-1
  • 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
    Potential patient risk:-performance issues have been identified during internal use of the reagent. it has been determined that there is a potential for weak or false negative results with some leb positive blood cells.
  • Action
    Affected units are being recalled from the market. This action has been closed-out on 20/06/2016.

Device

ALBAclone Anti-Leb, (LEB2) 1 x 5mL(Immunoglobulins capable of binding to specific red blood cell ...
  • Model / Serial
    ALBAclone Anti-Leb, (LEB2) 1 x 5mL(Immunoglobulins capable of binding to specific red blood cell antigens and intended to be used in immunohaematological testing to provide information about red blood cell antigen phenotypes.)Product Code: Z217Lot Number : V158461ARTG Number: 225063
  • Manufacturer
    Haemokinesis Pty Ltd

Manufacturer

Haemokinesis Pty Ltd