| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00442-1 |
| Product Name/Description |
ADVIA Centaur TnI-Ultra
Siemens Material Numbers: 10317708 and 10317709
Lots numbers ending in 088, 089, 090, 091, 093 and 094 and all future lots until issue is resolved
ARTG number: 175197
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has observed a system-to-system bias between the TnI-Ultra assay on the following systems:
- ADVIA Centaur CP and
- ADVIA Centaur
- ADVIA Centaur XP
- ADVIA Centaur XPT
The ADVIA Centaur CP is generating lower results than the ADVIA Centaur/ADVIA CentaurXP/ADVIA Centaur XPT system. Siemens is actively pursuing the cause of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing end users with information to assist with the interpretation and release of troponin results. Siemens internal investigation has confirmed the clinical utility of the assay at the 99th percentile for healthy individuals (0.02 - 0.06 ng/mL (µg/L)) is not impacted by this issue.
This action has been closed out on 17/09/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |