| TGA Action ID |
RC-2025-RN-00564-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
IDS Ostase BAP EIA 96w. An in vitro diagnostic medical device (IVD)
Lot Number: J59028 |
| ARTG Number |
186315 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
At release of the kit lot and at all previous stability testing timepoints, QC specifications were met. However, results obtained at the latest scheduled timepoint (03 Jun 2025) indicated a decreasing bias of the QC panel, which is now at a mean bias of -23% from initial release.
No similar occurrences have been observed within the past two years. |
| Instructions for Customers/Users |
Customers are to:
- Quarantine Lot number J59028 immediately
- Complete the Customer Response Form to request replacement product, or to indicate having no affected stock
- Destroy affected stock of Lot number J59028 once replacement product is received.
This action has been finalised on 18/9/2025. |
| Action Commencement Date |
24/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 222 287 - Abacus dx Pty Ltd |