| TGA Action ID |
RC-2026-RN-00429-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Copper. An in vitro diagnostic medical device (IVD)
Copper (R1b Reagent)
Catalogue Number: CU006/002/UL
Batch/Lot Number: 860855
Copper
Catalogue Number: CU2340
Batch/Lot Number: 860847
Expiry Date: 28/03/2028 |
| ARTG Number |
199616 |
| Unique Device Identifier (UDI) |
05055273201949 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A dispense problem has been identified with Copper Reagent CU2340 Batch 860847 and CU006/002/UL Lot 860855, where the volume supplied is lower than expected compared to previous lots. |
| Instructions for Customers/Users |
Customers are to quarantine the affected component and provide proof of scrappage for replacements to be provided. |
| Action Commencement Date |
5/06/2026 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |