| TGA Action ID |
RC-2026-RN-00859-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Rabbit Monoclonal Antibody (0.1 mL Concentrate). An in vitro diagnostic medical device (IVD).
Product Code: 354R-14 TFE3 (MRQ-37)
Lot Number: 0000559553 |
| ARTG Number |
239099 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Routine stability testing identified that the 0.1 mL concentrate size of TFE3 (MRQ-37) Rabbit Monoclonal Antibody may produce weak or no staining as the product ages, prior to expiry.
Weak staining may result in an inconclusive result requiring retesting, while no staining may result in a false-negative or incorrect result. |
| Instructions for Customers/Users |
Customers are to:
- Inspect stock and identify any affected lots.
- Destroy all affected stock on site as per local policy.
- Replacement product or a credit will be provided for affected stock. |
| Action Commencement Date |
22/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 222 287 - Abacus dx |