| TGA Action ID |
RC-2025-RN-00374-1 |
| 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 number: 1248UE, 1264UE, 1265UE, 1264UE, Packed into batches 610445, 606991
Expiry date: 28th Jan 2026, 28th Dec 2025
Manufacturing date: 2nd May 2022, 19th July 2022, 20th Oct 2022, 06th July 2022 |
| ARTG Number |
207886 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Certain lots and batches of the Human Assayed Multi-Sera Level 3 have the analyte NEFA increased over the shelf life of the product and requires the targets and ranges to be reassigned.
As a result, there may be delay in testing patient samples and/or a delay in reporting patient results. However, NEFA is not a standalone assay used for diagnostic testing of the patient’s lipid profile. |
| Instructions for Customers/Users |
Randox Laboratories has reassigned the Human Assayed Multi-Sera Level 3 targets and ranges.
The value sheets have been updated and are available on www.randox.com. Customers should discard the previous version and download the updated version.
Randox will provide updates once the root cause has been identified, and the Corrective and Preventive Actions (CAPA) have been completed.
This action has been finalised on 22/10/2026. |
| Action Commencement Date |
7/04/2025 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |