| TGA Action ID |
RC-2026-RN-00149-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS System software and VITROS Chemistry Products Assay Data Disk. An in vitro diagnostic medical device (IVD).
VITROS XT 3400 and 4600 Chemistry Systems, 5600 and XT 7600 Integrated Systems
Catalogue Numbers: 684 4458, 680 2445, 690 0440, 680 2413, 680 2915, 684 4461, 627 2222
Affected Assay Data Disk (ADD) Data Release Versions (DRV): 6359 to 6365 |
| ARTG Number |
180199 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
QuidelOrtho received customer complaints describing the inability to find VITROS Chemistry Products Calibrator Kit 32 in the Calibration Programming menu lot configuration while trying to calibrate VITROS Chemistry Products Na+, K+, Cl-, and ECO2 assays. During the Assay Data Disk loading procedure, after selecting ‘All Assay Data’, the Calibrator Kit dialog prompts the operator to select either: ‘Use current kit’ or ‘Change kit’.
Customers using ADD data release versions 6359 - 6365 will experience a software anomaly where, selecting the ‘Use current kit’ option causes VITROS Systems previously configured to use VITROS Calibrator Kit 32 to unexpectedly switch to the VITROS Calibrator Kit 2 configuration during the ADD loading process. |
| Instructions for Customers/Users |
· Until your laboratory receives ADD DRV 6366, manually select VITROS Calibrator Kit 32 using the ‘Change kit’ option, when loading ADD DRVs 6359 – 6365.
· Upon receipt, load ADD DRV 6366 (or above) and manually select VITROS Calibrator Kit 32 using the ‘Change kit’ option. After initial loading of ADD DRV 6366 or above, it is no longer required to manually select VITROS Calibrator Kit 32 in subsequently loaded ADD DRVs. |
| Action Commencement Date |
26/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - QuidelOrtho Technical Services Centre |