Events

Recall of Oxoid Antimicrobial Susceptibility Discs with Vancomycin (VA30). 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-00029-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00029-1
  • 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 cartridges within this batch may contain individual discs with insufficient amount of antibiotic, resulting in smaller than expected amounts of inhibition. continued use of the affected lot could result in false indication of resistance to vancomycin.
  • Action
    End users are requested 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.

Device

Oxoid Antimicrobial Susceptibility Discs with Vancomycin (VA30). An in vitro diagnostic medical d...
  • Model / Serial
    Oxoid Antimicrobial Susceptibility Discs with Vancomycin (VA30). An in vitro diagnostic medical device (IVD)Product code: CT0058B Lot Number: 1174497ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand