Events

Recall of TM0268 GC Sugar Set. 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-2017-RN-01157-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01157-1
  • 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
    Thermo fisher received an internal technical investigation confirming that a specific lot of tm0268 gc sugar set may provide atypical performance when used with some strains of neisseria species. false negative results may be seen with the glucose reaction with some strains. continued use of this lot may result in incorrect results reporting or a delay to results reporting due to additional testing requirements.
  • Action
    1. Inspect and remove from further use all units from the affected batch number, then complete the supplied Facsimile Reply Form and return for a credit note to be issued.

Device

TM0268 GC Sugar Set. An in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia & New Zealand