| TGA Action ID |
RC-2025-RN-00843-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Evidence Investigator Analyser. An in vitro diagnostic medical device (IVD)
Catalogue number: EV3602
UDI: 5055273209952 |
| ARTG Number |
204223 |
| Unique Device Identifier (UDI) |
5055273209952 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Randox Laboratories have updated the Evidence Investigator Operator Manual to include details on Cyber Security, informing customers of security and cybersecurity recommendations. |
| Instructions for Customers/Users |
Customers are to be aware of the Technical Bulletin and updated manual.
This action has finalised on 6/11/2025. |
| Action Commencement Date |
1/10/2025 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |