| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01152-1 |
| Product Name/Description |
Thioglycollate Broth 5mL. An in vitro diagnostic medical device (IVD)
Product Code: TM4068
Lot Number: 1306295
ARTG NUmber: 214128 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Thermo Fisher's investigations found that some vials within some boxes within 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 anaerobes. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pathology laboratories are requested to inspect their stocks and remove from further use all units from the affected batch number. Requirement for review of patient results should be determined by the laboratory director. This action has been closed-out on 03/06/2016. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |