| TGA Action ID |
RC-2025-RN-00504-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS 4600 Chemistry Systems and VITROS 5600 and XT 7600 Integrated Systems. An in vitro diagnostic medical device (IVD).
Software Version: V3.2 - V3.8.3
UDI: 690 0440 (10758750033201), 680 2445 (10758750012343), 680 2915 (10758750007110), 680 2413 (10758750002740), 627 2222 (10758750035656),
684 4461 (10758750031610), 680 1752 (10758750006984), 680 1753 (10758750006991), 680 1754 (10758750007004), 680 2326 (10758750002603),
684 2905 (10758750030729)
ARTG's 180199 & 232265 |
| ARTG Number |
180199, 232765 |
| Action Type |
Recall / Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho has confirmed a problem that occurs when VITROS Diluent Packs are manually loaded without entering a shelf expiration date on VITROS 4600 Chemistry Systems and VITROS 5600 and XT 7600 Integrated Systems.
Despite the “Use Expired Reagents” option not enabled, if a VITROS Diluent Pack Lot is manually loaded on the affected systems with the shelf expiration date left blank, the VITROS System will flag the pack as expired but report results, applying an RE code to the results.
When an RE code is applied to results, the time taken to troubleshoot and investigate the associated RE code may result in delayed patient results.
To date, QuidelOrtho has received 1 complaint related to this problem, with no reports of adverse effects. |
| Instructions for Customers/Users |
QuidelOrtho is working on a software update to resolve this problem. In the meantime, customers are to:
- Enter the shelf expiration date manually when loading VITROS Diluent Packs on affected systems.
- View the Reagent Management Supply 3 screen to check for any onboard VITROS Diluent Packs marked as expired.
- For all VITROS Diluent Packs marked as expired, navigate to View By Reagent à View Dil/ANC and confirm the shelf expiration date matches the shelf expiration date on the product labeling. If the dates do not match, discard the VITROS Diluent Pack and load a new VITROS Diluent Pack.
QuidelOrtho will credit within-expiry products.
This action has been finalised on 9/7/2026. |
| Action Commencement Date |
30/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - Technical Services Center |