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 |