| TGA Action ID |
RC-2025-RN-00159-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
UTAK Validity Control 2. An in vitro diagnostic medical device (IVD)
Part number: 17011
UDI number: 00630414974750
Lot number: D4723
Manufacturing date: Feb-2024
Expiry date: 28-Feb-2026
ARTG 279922
(Siemens Healthcare Pty Ltd - Clinical chemistry toxicology/drug detection IVDs) |
| ARTG Number |
279922 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
UTAK has received a customer report of black particles found in some vials of UTAK Validity Control 2. Investigation is underway, and remaining inventory was quarantined. The matter is undergoing third-party testing to identify the particulate matter.
Current evidence indicates that the vials without visible particulate matter may be used. |
| Instructions for Customers/Users |
Customers are to:
- observe material before use, discard the vials containing particulate matter
- continue using vials with no visible particulates or return them for a replacement
This action has been closed out on 28/05/2025 |
| Action Commencement Date |
3/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Center |