| TGA Action ID |
RC-2026-RN-00130-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS XT 3400 and 4600 Chemistry Systems, and VITROS 5600 and XT 7600 Integrated Systems. An in vitro diagnostic medical device (IVD).
Product Codes: 684 4458, 680 2445, 690 0440, 680 2413, 680 2915, 684 4461, 627 2222 |
| ARTG Number |
180199 |
| Action Type |
Product Correction / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho received a customer complaint detailing that their automation track system aspirated samples before their VITROS System had transitioned from the status of “Not Ready, Equilibrating Environment” to “Ready”. The VITROS System status of “Not Ready, Equilibrating Environment” was due to the Slide Supply 1 relative humidity not meeting the on-board storage requirements.
A software anomaly results in miscommunication between the VITROS System software and the automation track software. This problem impacts all available versions of the VITROS System software with the potential to lead to erroneous results.
This problem will be resolved in a future software update. |
| Instructions for Customers/Users |
Customers are to resolve TA7-XXX Condition Codes related to Slide Supply relative humidity as soon as possible.
QuidelOrtho will resolve this problem in a future software update. |
| Action Commencement Date |
20/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - QuidelOrtho Technical Services Centre |