| TGA Action ID |
RC-2025-RN-00630-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS Chemistry Products Ca Slides, Generations 67 and Above. An in vitro diagnostic medical device (IVD)
VITROS XT 3400 Chemistry System
VITROS XT 7600 Integrated System
VITROS XT 7600 Integrated System - Certified
Catalogue numbers: 1450261, 6844458, 6844461, 627 2222 |
| ARTG Number |
180199, 232249 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho has reported a problem affecting VITROS Chemistry Products Ca Slides. It has been observed that users may experience a higher rate of calibration failures when attempting to calibrate these slides on VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. Specifically, Generations 67 and above of the VITROS Ca Slides are more likely to trigger Condition Code TH4-63J during calibration.
This code is generated when the REFLECTOMETER detects image variations that exceed the assay limits defined on the Assay Data Disk (ADD), potentially resulting in calibration failure.
The problem may lead to delays in obtaining patient results due to the time required to troubleshoot failed calibrations, which could impact patient management depending on the length of the delay and the clinical urgency of the test. |
| Instructions for Customers/Users |
Customers are to:
· Load ADD DRV 6338 onto their VITROS XT 3400 and/or VITROS XT 7600 System(s) upon receipt.
· Retain this notification with their User Documentation or display it near each VITROS XT 3400/VITROS XT 7600 System in the laboratory until the problem is resolved.
· Forward this notification if the affected product has been distributed outside of their facility.. |
| Action Commencement Date |
16/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - Technical Services Center |