Events

Recall of Oxoid Xpect Legionella Test Kit (R24680), 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 Thermo Fisher Scientific Australia & New Zealand.

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-00159-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00159-1
  • 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 cassettes within this lot of oxoid xpect legionella test kit may produce false positive results. continued use of this lot could result in the false reporting of the presence of legionella pneumophila serogroup 1 and 6 antigens in human urine samples.
  • Action
    Thermo Fisher Scientific is requesting their customer to inspect their stock and quarantine any affected units. Upon confirmation of affected stock Thermo Fisher Scientific will provide a credit note.

Device

Oxoid Xpect Legionella Test Kit (R24680), an in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia & New Zealand