Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20135 |
| Brand Name: | Siemens ADVIA Centaur, ADVIA Centaur XP,ADVIA Centaur XPT, ADVIA Centaur CP Tnl-Ultra |
| Model: | Tnl-Ultra (100 test) 02789602, Tnl-Ultra (500) 02790309 |
| Affected: | multiple lot numbers |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd 55 Hugo Johnston Drive Penrose Auckland |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | The manufacturer has confirmed that all in date lots of ADVIA Centaur TnI-Ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). The Instructions for Use (IFU) state that specimens that have up to 10 ng/mL (41 nmol/L) of biotin demonstrate = 10% change in results. The biotin level in a general population is approximately 0.3 to 1.0 ng/mL (1.2 to 4.3 nmol/L). |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/5/2016 |





