| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00694-3 |
| Product Name/Description |
CT1133S Cephalexin 100ug CL100 Antimicrobial Susceptibility Discs (Used for antimicrobial susceptibility testing), An in vitro diagnostic medical device (IVD)
Batch Number: 1129970 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer's investigations confirmed that some cartridges within this batch may contain individual discs that are not sufficiently dosed with antibiotic. Continued use of this lot could therefore result in false indication of resistance. |
| Recall Action |
Recall |
| Recall Action Instructions |
Remove all affected lots from use and return to Oxoid Australia. This action has been closed-out on 02/02/2016. |
| Contact Information |
08 8238 9044 - Oxoid Australia Regulatory Affairs |