| 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 |
|
| 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 |