Events

Recall of Amoxicillin + clavulanic acid 20 & 10 ìg discs. 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 Bio-Rad Laboratories 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-2014-RN-00856-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00856-1
  • 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
    Following two customers complaints reporting false resistance, we have identified a risk that amoxicillin+clavulanic acid disks could discharge during their use. the stability of amoxicillin + clavulanic acid combination might deteriorate over time in the conditions of routine use, even if following bio-rad storage recommendations (at 2-8°c with desiccant).
  • Action
    To limit the risk of releasing false resistances results, Bio-Rad is requesting their customers to stop using the concerned lot and to destroy the remaining containers locally. This action has been closed-out on 02/06/2016.

Device

Amoxicillin + clavulanic acid 20 & 10 ìg discs. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Amoxicillin + clavulanic acid 20 & 10 ìg discs. An in vitro diagnostic medical device (IVD).Catalogue Number: 66178Batch Number: 4D5612 ARTG Number: 192139
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd