Events

Recall of Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin, CT1644B

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-2015-RN-01185-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01185-1
  • 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
    An internal investigation has confirmed that oxoid antimicrobial susceptibility testing disc qd15 quinupristin / dalfopristin may contain a small number of discs that produce variable results. not all of the lot is affected, however, it has been identified that some discs may produce larger than expected or unexpected zones of inhibition.Continued use of this lot could result in quality control failures, delayed results or false susceptibility reporting.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units. Results issued with the above batch should be reviewed against case histories, other results and other relevant individual data.

Device

Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin, CT1644B

Manufacturer

Thermo Fisher Scientific Australia & New Zealand