| TGA Action ID |
RC-2025-RN-00986-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Elecsys Anti-TSHR. An in vitro diagnostic medical device (IVD).
For use on cobas e801 & 402 (E2G):
Material Number: 08496633190
Lot Number(s): 840183, 874011
For use on cobas e411 (E1G):
Material Number: 08496609190
Lot Number: 840177 |
| ARTG Number |
174907 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Roche has received reports of two related problems with the Elecsys Anti-TSHR.
1. Results Vary by Instrument Platform
The test results for the same patient sample are coming out significantly different depending on which instrument is used. On the cobas e 411 analysers, results are showing a higher reading than they should be. On the cobas e 801 and e 402 units, results are showing a lower reading than they should be.
2. Results Vary by Calibrator Lot (on the cobas e 411)
On the cobas e 411 analysers specifically, the results also change significantly when different lots of the test's calibrator are used.
There are no reports of patient harm linked to this problem. |
| Instructions for Customers/Users |
- All customers that have the affected products must immediately stop using the current lots on cobas e 411, cobas e 402 and cobas e 801 and switch to the new lots 906872 (E1G) and 908953 (E2G).
- Customers using cobas e 60x can proceed using all currently available and the upcoming lots.
- Roche will be in contact with customers regarding replacement of current stock. |
| Action Commencement Date |
26/11/2025 |
| Responsible Entity |
|
| Contact Information |
1800 645 619 - Roche Diagnostics |