Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18574 |
| Brand Name: | Siemens Centaur Tnl Ultra |
| Model: | SMN: 10317708 (100 test kit), 10317709 (500 test kit) |
| Affected: | Kit Lots ending in 088, 089, 090, 091, 093 and 094 and all future lots until the issue is resolved and a follow-up communication is issued |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | Siemens Healthcare Diagnostics has observed a system-to-system bias between the TnI-Ultra™ assay on the ADVIA Centaur® CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems with the ADVIA Centaur CP generating lower results than the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT system. Siemens is actively pursuing the cause of this issue. This observation impacts customers who use the TnI-Ultra assay on both the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems interchangeably when interpreting serial testing in patient samples. This communication does not impact customers who use TnI-Ultra results solely from either the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT system or the ADVIA Centaur CP system. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/5/2015 |
