Events

Recall of Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (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-2014-RN-00135-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00135-1
  • 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 dr0802 oxoid legionella penumophila 2-14 reagent, lot 1265366 may return false negative tests. continued use of this lot may result in a delay to the correct serogroup characterisation of legionella isolates.
  • Action
    Thermo Fisher Scientific is advising users to inspect stock and remove all affected lots from use. Thermo Fisher is advising that the requirement for review of patient results should be determined by the Laboratory Director.

Device

Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in v...
  • Model / Serial
    Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in vitro diagnostic medical device (IVD))Oxoid Legionella Latex Test (DR0800M)Lot Numbers: 1314413 and 1301907Oxoid Legionella Pneumophila Serogroup 2-14 Test Reagent (DR0802M)Lot Number: 1265362
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand