Events

Recall of Bio-Rad Multispot HIV-1 / HIV-2 Rapid Test. 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-01072-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01072-1
  • 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
    Bio-rad laboratories has received reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membranes when using some vials of conjugate in the multispot hiv-1 / hiv-2 rapid test.
  • Action
    Bio-Rad are recalling all affected lots and recommending the retesting of patient samples reported as negative under certain circumstances and at the discretion of the Laboratory Director.

Device

Bio-Rad Multispot HIV-1 / HIV-2 Rapid Test. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Bio-Rad Multispot HIV-1 / HIV-2 Rapid Test. An in vitro diagnostic medical device (IVD)Catalogue Number: 25228Reagent Kit Lot Number: 114284Conjugate Lot number: 114280ARTG Number: 53509
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd