| TGA Action ID |
RC-2025-RN-00418-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD).
Liquid Assayed Specific Protein Control L1
Catalog Numbers: PS2682, PS10221
Liquid Assayed Specific Protein Control L2
Catalog Numbers: PS2683, PS10222
Liquid Assayed Specific Protein Control L3
Catalog Numbers: PS2684, PS10223
multiple expiry dates and batch numbers |
| ARTG Number |
199684 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Rheumatoid Factor (RF) concentrations in Liquid Assayed Specific Protein Controls Level 1 Lots 647LPC and 686LPC are below the measurement range of nephelometric methods on Siemens instruments.
Randox can also confirm that Anti Streptolysin O (ASO) target and range values have been reassigned in lot no’s 706LPC, 707LPC, 708LPC, 709LPC and 710LPC.
They may cause a delay in testing patient samples and/or a delay in reporting patient results.
Investigation is ongoing, Randox Laboratories has removed the associated targets and ranges for RF and reassigned the targets and ranges for ASO. IFU has been updated. |
| Instructions for Customers/Users |
Randox Laboratories has reassigned the targets and ranges for ASO and removed the associated targets and ranges for RF.
Customers are to download the updated value sheets and discard the previous version.
This action has been closed out on 29/05/2025 |
| Action Commencement Date |
24/04/2025 |
| Responsible Entity |
|
| Contact Information |
02 9615 4640 - Randox Australia Office |