| TGA Action ID |
RC-2026-RN-00661-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Artisan Link Pro and Artisan Link System. An in vitro diagnostic medical device (IVD).
Part Number: AR31030, AR31027, AR21030 |
| ARTG Number |
181957 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Under certain operating conditions, Artisan Link Pro instruments may experience reagent liquid overflow that can expose the heater boards to liquid. This typically occurs when the slide clip does not form a proper seal against the slide, allowing reagent to leak from the reagent bath into the instrument and onto the heater electronics.
If reagent liquid contacts the heater board electronics, the affected heater board may experience a short circuit or other electrical malfunction. As a result, the associated heater plate may operate at a higher temperature, fail to reach the intended temperature, or cease heating altogether.
There is a remote chance of receiving minor burns as a result of touching the heater plate if it has remained on at a high temperature. There is also a possibility that a short circuit could result in the self-limiting ignition of a small quantity of ethanol containing reagents. These conditions may also impact instrument performance and could result in interrupted or unsuccessful staining runs. |
| Instructions for Customers/Users |
Agilent is requesting customers to follow the Basic User Guide/Instructions for Use:
1. Power off the instrument and contact Agilent service if there are signs of liquid overflow, heating issues, irregularities, or malfunctions.
2. Avoid hot heating elements, the heater plate, and the slide carousel surface, as these may cause burns.
3. Use the designated tabs to rotate the carousel safely.
4. Tighten all waste bottle caps before operation.
5. Ensure the “Waste Valve Rinse” option is enabled before use.
6. Complete all recommended maintenance and operating procedures in the User’s Guide.
7. Use small, securely attached flap labels; do not double-label slides.
8. Check the drip tray after each run.
9. Use slide clips once only and store them as directed on the packaging.
10. Run the “Prime All” function before each run.
For problems or questions customers should contact their local technical support representative. |
| Action Commencement Date |
1/09/2026 |
| Responsible Entity |
|
| Contact Information |
(03) 9566 1723 - Enia Kakaflikas |