Events

Recall of CEFOTAXIME CT 256 WW F100. 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 Biomerieux Australia Pty Ltd.

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-00516-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00516-1
  • 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 identified a performance deviation associated with quality control testing of retained product samples. the qc results were out of range resulting in false resistant strains.
  • Action
    BioMerieux is requesting their customers to discontinue using and discard any remaining inventory of Etest CEFOTAXIME CT 256. This action has been closed-out on 18/08/2016.

Device

CEFOTAXIME CT 256 WW F100. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    CEFOTAXIME CT 256 WW F100. An in vitro diagnostic medical device (IVD)Serial Number: 1002774320 ARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd