| TGA Action ID |
RC-2026-RN-00546-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 with iQM3. An in vitro diagnostic medical device (IVD).
Multiple part numbers |
| ARTG Number |
228036 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Following customer reports, a review of sodium (Na+) results from normal patient populations on the GEM Premier 5000 and GEM Premier 7000 systems shows a negative bias of approximately 3 mmol/L relative to the published serum reference range.
A negative bias may impact patient results and/or influence medical decision making. This could result in false reports of hyponatremia, or the failure to detect borderline hypernatremia results. |
| Instructions for Customers/Users |
Werfen will implement an adjustment to the Na+ setting in future PAK lots. This adjustment applies a shift of approximately +3 mM across the Na+ analytical measurement range.
This adjustment applies to future PAK lots only, and does not require removal of PAKs currently in use.
Customers are to:
- Evaluate whether adjustment or removal of any custom Na+ correlation coefficients is required prior to implementation of the optimised PAKs, if applicable.
- Consider review of previous patient results as necessary, considering all relevant clinical information. |
| Action Commencement Date |
21/08/2026 |
| Responsible Entity |
|
| Contact Information |
1300 369 132 - Werfen Australia Customer Service |