| TGA Action ID |
RC-2025-RN-00847-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
In-Line Red Cell Filtration System
Reference: LQT614B
Batch Number: 11525352BM
Expiry Date: 11/2026 |
| ARTG Number |
142856 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Macopharma identified a significant increase in the leak rate in red blood cell concentrate storage bags.
These leaks result in an excess of SAGM solution in the overwrap or from solution leakage during the blood product preparation process. The leak is located at the base of the central tube of the bag, or at the base of the QC sampling line.
This type of defect can be detected at different stages:
- Before use of the product by an excess amount of solution within the overwrap.
- During the preparation of blood products (before or after centrifugation) by solution leakage from the central or QC sampling tube of the bag.
The leak is visible and easily detectable by the operator under normal operating conditions (leak under simple gravity), during pre-use inspection or during blood product processing.
Currently, the Global incident rate is around 0.03%. |
| Instructions for Customers/Users |
A visual inspection by operators must be systematically carried out before use to check for the presence of leaks.
If an impacted product is identified, it must not be used and can be returned to Macopharma for full investigation.
This action has been closed out on 16/01/2026 |
| Action Commencement Date |
3/10/2025 |
| Responsible Entity |
|
| Contact Information |
02 9904 7303 - Denis Kocina, MacoPharma Australia Pty Ltd |