| TGA Action ID |
RC-2026-RN-00421-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Liquichek Tumor Marker Control. An in vitro diagnostic medical device (IVD).
Catalogue Numbers: 547, 548, 549, 548X
Lot Numbers: 1006710 series
Expiry Date: 06/30/28 |
| ARTG Number |
225356 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Internal testing reported that the In-Use stability claims for ProGRP (Progastrin-Releasing Peptide) in Liquichek Tumor Marker Batch 1006710 were not met.
All other claims for this lot of Liquichek Tumor Marker Control remain unchanged. |
| Instructions for Customers/Users |
Customers are to obtain the revised package insert from http://myeinserts.qcnet.com and discard all previous versions that users may have at their location.
This action has been finalised on 15/9/2026. |
| Action Commencement Date |
4/06/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 9914 2800 - Bio-Rad Laboratories |