| TGA Action ID |
RC-2026-RN-00469-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
LIFECODES LSA Class II Kit (CE). An in vitro diagnostic medical device (IVD).
Part Number: 265200
Lot Numbers: 3016677, 3016531, 3016316, 3016099
Expiry Dates: 22-Dec-26, 22-Oct-26, 26-Aug-26, 01-Jul-26 |
| ARTG Number |
217870 |
| Unique Device Identifier (UDI) |
88823411W01030402C002GJQ |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Werfen has identified that two beads within the LIFECODES LSA Class II assay will present different DQB1 specificities than previously understood.
Due to this problem, certain reactivity patterns may appear differently than expected.
Bead 42 / Antigen ID 242
- Previously associated with DQB1*02:01, this bead instead presents DQB1*02:02
Bead 44 / Antigen ID 244
- Previously associated with DQB1*02:02, this bead instead presents DQB1*02:01
Note: DQA1*02:01 is present on both beads and therefore not impacted.
Patient risk is considered low. Due to built-in redundancy across multiple beads representing DQB1*02:01 and DQB1*02:02 specificities, the assay remains capable of qualitatively detecting IgG antibodies to these specificities. |
| Instructions for Customers/Users |
Customers are to:
- Import revised EDS files for the affected lot(s) to ensure all future analyses use the corrected antigen mapping.
- Review impacted reactivity patterns to confirm whether previously reported results may be affected based on the patterns shown in the Customer Letter.
This action has been closed out on 24/09/2026 |
| Action Commencement Date |
23/06/2026 |
| Responsible Entity |
|
| Contact Information |
1300 369 559 - Paragon Care Group Australia |