| TGA Action ID |
RC-2026-RN-00650-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Trinity Biotech Oxalate Reagent B and Oxalate Kit. An in vitro diagnostic medical device (IVD)
Product Code: 591-2 and 591-D
Affected Lots: 2500711 and 2502503 |
| ARTG Number |
203620 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Trinity Biotech identified a performance variability in Oxalate Reagent B Lot 2500711, resulting in vial-to-vial inconsistency that may cause a negative bias and under-recovery of urinary oxalate results. The problem is limited to Oxalate Reagent B Lot 2500711 and Oxalate Kit Lot 2502503 containing that reagent lot. All other lots remain within specifications.
To date, no serious injury or adverse events have been reported due to this problem. |
| Instructions for Customers/Users |
Customers are to:
· Immediately identify and quarantine all inventory of Oxalate Reagent B Lot 2500711 and Oxalate Kit Lot 2502503 containing Oxalate Reagent B Lot 2500711.
· Dispose of the affected inventory in accordance with any facility established procedures.
· Trinity Biotech will be replacing all affected Oxalate Reagent B Lot 2500711 and Oxalate Kit Lot 2502503 containing this reagent lot. |
| Action Commencement Date |
1/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 252 215 - Immuno |