| TGA Action ID |
RC-2025-RN-00544-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS Chemistry Products Performance Verifier I and II. An in vitro diagnostic medical device (IVD).
Used with VITROS Chemistry Products CHE Slides
Catalogue numbers: 806 7324, 823 1474, 191 4605, 800 4707
Lots: All lots within expiry |
| ARTG Number |
232247, 245278 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho determined that VITROS Performance Verifiers I and II, when stored at 2–8°C, maintain reconstituted stability for up to 48 hours. However, they may not maintain this stability for up to 7 days for CHE, as specified in the Performance Verifier Assay Sheets.
A drift in the results of VITROS Performance Verifiers I and II below established ranges can lead to QC failure, potentially delaying patient results. In certain cases, this drift in QC results may result in the acceptance of a sub-optimal calibration, which could produce biased patient results. The maximum observed (simulated) bias was noted to be +0.68 U/mL. QuidelOrtho does not recommend reviewing previous results, citing the low likelihood of biased patient outcomes. |
| Instructions for Customers/Users |
Customers are to monitor VITROS CHE Slides QC results to identify any drift in VITROS Performance Verifiers I and II falling below 2x Within-lab SD limits. If such a drift is observed, QC should be repeated using freshly reconstituted vials of VITROS Performance Verifiers I and II. |
| Action Commencement Date |
12/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - Ortho-Clinical Diagnostics Australia Technical Services Center |