| TGA Action ID |
RC-2026-RN-00667-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Liquid Urine Control and Liquid Assayed Chemistry Control Premium Plus. An in vitro diagnostic medical device (IVD)
Liquid Urine Control - Level 2
Catalogue Number: UC5074
Batch/Lot Number: 1389UC
Expiry: 28/02/2027
Liquid Assayed Chemistry Control Premium Plus - Level 2
Catalogue Numbers: LAN4214
Batch/Lot Numbers: 1815UN
Expiry: 28/06/2027
Liquid Assayed Chemistry Control Premium Plus - Level 3
Catalogue Numbers: LAE4215
Batch/Lot Numbers: 1505UE
Expiry: 28/09/2027 |
| ARTG Number |
204567, 207886 |
| Unique Device Identifier (UDI) |
05055273207569, 05055273208986 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Customers may be unable to use the product due to QC being outside range. This may lead to a delay in reporting results.
The targets and ranges in the instrument section “Abbott Alinity / Architect c/ci Systems” for the analyte Sodium in UC5074 Liquid Urine Control – Level 2 lot 1389UC have been reassigned.
The targets and ranges in the instrument section “Abbott Alinity / Architect c/ci Systems” for analytes: Alkaline Phosphatase, Creatinine and HDL Cholesterol in LAN4214 Liquid Assayed Chemistry Control Premium Plus - Level 2 lot 1815UN have been reassigned. The analyte ALT in LAE4215 Liquid Assayed Chemistry Control Premium Plus - Level 3 lot 1505UE have been reassigned. |
| Instructions for Customers/Users |
Customers are to:
- Refer to the reassigned targets and ranges in the customer letter.
- Download the corrected Instructions for Use and discard previous copies. |
| Action Commencement Date |
31/08/2026 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia |