Events

Recall of Genscreen HIV Ag/Ab Ultra. 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 Bio-Rad Laboratories 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-2012-RN-00954-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00954-1
  • 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
    As a tga condition for product registration, the genscreen hiv ag/ab ultra was accepted for 9 months shelf life not 12 months as stated on the packaging. the genscreen hiv ag/ab ultra kit was distributed to customers after may 2011 without the warning label: "customers are advised to subtract 3 months from the expiry date to obtain the new expiry date of the kit".
  • Action
    Customers are being advised that for lots within the TGA accepted shelf life investigation of result validity should be carried out as per the package insert and for lots used outside of the accepted shelf life retesting of patient samples should be considered at the discretion of the laboratories Clinical Laboratory Director.

Device

Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 72386 and 72388Multiple lot numbersARTG Number: 134410
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd