| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01246-1 |
| Product Name/Description |
Oxoid Anti-microbial Susceptibility Testing Disc for Nitrofurantoin. An in vitro diagnostic medical device (IVD)
F200 (Nitrofurantoin)
CT0035B
Lots 1194943
F300 (Nitrofurantoin)
CT0036B
Lots 1191121
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
A technical investigation has indicated that cartridges of the affected lots may present atypical results. Continued use could result in a false indication of sensitivity to Nitrofurantoin. |
| Recall Action |
Recall |
| Recall Action Instructions |
Return affected lots to Oxoid Australia for replacement with unaffected stock. |
| Contact Information |
08 8238 9044 - Oxoid Australia Regulatory Affairs |