| TGA Action ID |
RC-2026-RN-00106-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS Immunodiagnostic Products Progesterone 2 Calibrators & VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack. An in vitro diagnostic medical device (IVD).
Product Codes: 619 9455 & 619 9454
Lot Numbers: 0050, 0060, 0070, 0080, 0090, 0140, 0150, 0160
Expiry Dates: 03-Feb-2026, 04-Mar-2026, 11-Mar-2026, 31-Mar-2026, 06-May-2026, 17-Sep-2026, 28-Oct-2026, 10-Nov-2026
|
| ARTG Number |
176641 |
| Unique Device Identifier (UDI) |
10758750035373, 10758750035366 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho, through customer complaints, has identified a problem with their VITROS Prog2 Calibrators. There is an unexpected increase in signal over time in VITROS Prog2 Calibrators, Levels 2 and 3. This may cause:
o Calibration failures when attempting to calibrate impacted lots of VITROS Prog2 Reagent Pack.
o Quality control (QC) failures with results above the limit, due to a sub-optimal passing calibration, when performing QC on impacted lots of VITROS Prog2 Reagent Pack.
To date, QuidelOrtho has received 125 complaints related to this problem, with no reports of adverse effects. |
| Instructions for Customers/Users |
Customers are to:
- Follow the steps outlined in the Customer Letter to recalibrate the systems.
- Complete the Customer Response Form and return it to mikaela.rasile@quidelortho.com. |
| Action Commencement Date |
6/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - QuidelOrtho Technical Services |