Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00856-1
Product Name/Description Amoxicillin + clavulanic acid 20 & 10 ìg discs. An in vitro diagnostic medical device (IVD).

Catalogue Number: 66178

Batch Number: 4D5612

ARTG Number: 192139
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 1/08/2014
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue 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).
Recall Action Recall
Recall Action Instructions 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.
Contact Information 1800 224 354 - Bio-Rad Laboratories