| TGA Action ID |
RC-2026-RN-00793-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Troponin T Control. An in vitro diagnostic medical device (IVD).
Catalogue Number: CQ10450
Batch/Lot Number: 5035CK
Expiry Date: 28/06/2027 |
| ARTG Number |
208141 |
| Unique Device Identifier (UDI) |
05055273216875 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The stability of troponin T in the Troponin T Control does not meet the claim stated on the Instructions for Use (IFU), following thawing of the material and storing at refrigerated temperature (+2°C to +8°C).
Customers may be unable to use QC for the claimed stability period, which could lead to a delay in running samples.
|
| Instructions for Customers/Users |
Customers are to:
- Discontinue use of the affected stock.
- Discard the stock on site as per policy.
- Provide proof of destruction to the Sponsor to receive replacement stock. |
| Action Commencement Date |
8/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |