| TGA Action ID |
RC-2026-RN-00844-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS Chemistry Products A1c Slides. An in vitro diagnostic medical device (IVD).
Catalog Number: 684 4520
Affected GENs & Expiry Dates: 05 (1/3/2026), 38 (01/11/2026), 42 (01/11/2026), 45 (01/11/2026), 46 (01/02/2027), 48 (01/12/2027), 49 (01/02/2027), 43 (01/08/2026), 44 (01/08/2026) |
| ARTG Number |
232247 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho has received complaints relating to certain GENs of VITROS A1c Slides generating positively biased HbA1c results. Investigation confirmed that GENs 05, 38, 42, 45, 46, 48 and 49 may be affected by this problem. |
| Instructions for Customers/Users |
Customers are to:
- Discontinue use of affected GENs of VITROS A1c Slides, render remaining inventory unusable and discard it. |
| Action Commencement Date |
21/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - Technical Services Centre |