Events

Recall of Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. 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-2016-RN-01115-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01115-1
  • 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
    Investigation by oxoid has identified that a single lot of oxoid antimicrobial susceptibility testing disc ceftazidime may contain discs with a reduced concentration of antibiotic, which may impact on performance. testing with pseudomonas aeruginosa atcc 27853 (eucast quality control organism) returned lower than specified zones of inhibition. continued use of this lot could result in quality control failures, delayed results or incorrect results reporting (false resistance).
  • Action
    Thermo Fisher is advising users to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 11/05/2017.

Device

Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. An in vitro diagnostic medic...
  • Model / Serial
    Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)Product Code: CT1629BLot Number: 1426486ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand