Events

Recall of Oxoid Antimicrobial Susceptibility Testing Disc for Penicillin G (P1). 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-2015-RN-01149-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01149-1
  • 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 technical investigation by oxoid limited, part of thermo fisher scientific, has confirmed that oxoid antimicrobial susceptibility testing disc penicillin g (p1), ct0152b lot 1675623 may contain a small number of discs that produce variable results. not all of the lot is affected however our investigation identified that the size of the inhibition zone varied significantly with some discs producing larger than expected, unexpected or irregular zones of inhibition.Continued use of this lot could result in quality control failures, delayed results or false susceptibility reporting.
  • 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. This action has been closed-out on 22/08/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Disc for Penicillin G (P1). An in vitro diagnostic med...
  • Model / Serial
    Oxoid Antimicrobial Susceptibility Testing Disc for Penicillin G (P1). An in vitro diagnostic medical device (IVD)Product Code: CT0152BLot Number: 167623ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand