| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00728-1 |
| Product Name/Description |
Thioglycollate Medium (bacteria culture media). An in vitro diagnostic medical device (IVD)
Product code: TM0935
Lot number: 1291980
ARTG number: 214128 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Investigations have confirmed that some vials within some boxes of this batch may fail to support the growth of Clostridium sporogenes. Continued use of this lot could result in failure to detect this or similar anaerobic bacteria. The medium was found to still support the growth of all aerobic bacteria tested. |
| Recall Action |
Recall |
| Recall Action Instructions |
Oxoid Australasia is requesting their customers remove any affected stock from further use. Arrangements will be made for replacement or credit note to be provided. |
| Contact Information |
08 8238 9044 - Oxoid Australasia |