Events

Recall of Streptex Group D Latex agglutination reagent R30950901, 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 Oxoid Australia 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-2013-RN-00342-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00342-1
  • 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
    Investigations by the manufacturer have confirmed that latex reagent within this batch may give weak or false negative results. continued use of this lot could result in false negative results with some cultures.
  • Action
    Oxoid is asking customers to destroy the affected reagents.

Device

Streptex Group D Latex agglutination reagent R30950901, An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Streptex Group D Latex agglutination reagent R30950901, An in vitro diagnostic medical device (IVD)Lot number: 1149576
  • Manufacturer
    Oxoid Australia Pty Ltd

Manufacturer

Oxoid Australia Pty Ltd