| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01089-1 |
| Product Name/Description |
CT0034B Nitrofurantoin 100ug F100 Antimicrobial Susceptibility Discs. An in vitro diagnostic medical device (IVD)
Batch Number: 1195942 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
Investigations by the manufacturer, Oxoid Limited, have confirmed that cartridges within this batch may present atypical results. Continued use of this lot could result in false indication of sensitivity to nitrofurantoin. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and remove all affected stock from use. |
| Contact Information |
08 8238 9044 - Oxoid Australia Regulatory Affairs |