| TGA Action ID |
RC-2026-RN-00331-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Human Assayed Multi-Sera Level 3. An in vitro diagnostic medical device (IVD).
Catalogue Number: HE1532, HS2611
Batch/Lot Numbers: 1480UE, 1441UE, 1479UE, 1521UE, 1481UE, 772647
Expiry Dates: 28/04/2029, 28/12/2028 |
| ARTG Number |
207886 |
| Unique Device Identifier (UDI) |
05055273203608, 05055273203813 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Analyte LDH has been assigned incorrectly in certain batch/ lot numbers and requires the targets and ranges to be reassigned on the Randox RX series. |
| Instructions for Customers/Users |
· Randox Laboratories has updated the targets and ranges for LDH.
· The value sheets have been updated and are available on www.randox.com.
Customers must discard the previous version and download the updated version. |
| Action Commencement Date |
4/05/2026 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |