| TGA Action ID |
RC-2026-RN-00622-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS Chemistry Products VALP Reagent. An in vitro diagnostic medical device (IVD).
Catalogue Number: 680 1710
Lots: 2511-35-3174, 2511-36-3272, 2511-37-3554
Expiry: 17-Aug-2026, 01-Nov-2026, 27-Feb-2027 |
| ARTG Number |
245278 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho confirmed a problem involving VITROS Chemistry Products VALP Reagent. Lots from Generations (GENs) 35, 36, and 37 may generate positively biased results. QuidelOrtho’s investigation into the problem determined that lots from GENs 35, 36, and 37 of VITROS VALP Reagent may experience a drift in performance across the shelf life of the product. A drift in performance may cause positively biased results as the product ages.
To date, no adverse events have been reported due to this problem. |
| Instructions for Customers/Users |
Customers are to:
• Discontinue using, render unusable, and discard all inventory of affected lots of VITROS VALP Reagent.
• Complete the Customer Response Form. QuidelOrtho will credit or replace discarded inventory. |
| Action Commencement Date |
14/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - QuidelOrtho Technical Services |