| TGA Action ID |
RC-2026-RN-00560-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Fertilisation Medium FEM-50
Batch: J000007889
Manufacture Date: 29/04/2026
Expiry Date: 28/04/2027 |
| ARTG Number |
419435 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The endotoxin testing method has changed due to the end of life of the testing kits used by Genea Biomedx for quantifying endotoxin levels. The Instructions for Use (IFU) was not updated to remove the mention of the previous LAL test method. Specification remains the same, no other product change, no impact on product safety or performance. |
| Instructions for Customers/Users |
The updated hardcopy IFU with Endotoxin test method wording update will be shared by Genea Biomedx.
Customers are to:
- Replace the previous revision supplied. |
| Action Commencement Date |
27/07/2026 |
| Responsible Entity |
|
| Contact Information |
regulatory@geneabiomedx.com - Genea Biomedx |