Siemens Recalls ADVIA Centaur Tni-Ultra Assay Due to System Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Tni-Ultra Assay kits due to system-to-system bias between different ADVIA Centaur platforms.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a technical bias in diagnostic results rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Tni-Ultra Assay, including SMN 10317708 (100 tests) and SMN 10317709 (500 tests). The recall affects all in-date lots of reagents, specifically those with kit lots ending in 088, 089, 090, 091, 093, and 094, as well as all future lots until the issue is resolved.
The recall was initiated due to system-to-system bias between the Tni-Ultra assay when used on the ADVIA Centaur CP system compared to the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. This assay is used for the quantitative determination of cardiac troponin I in serum or plasma to aid in the diagnosis of acute myocardial infarction and risk stratification of acute coronary syndromes.
The affected products were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Asia, the Americas, and other regions. Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions and a follow-up communication.
The recalled product
- Product
- ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 089
- 090
- 091
- 2015 43818088 May 25
- 2015 44793088 May 25
- 2015 45687089 June 22
- 2015 46527089 June 22
- 2015 48096089 June 22
- 2015 49216090 August3
- 2015 50779090 August3
- 2015 52113091 September 14
- 2015 53091093 October 19
- 2015 54684093 October 19
- 2015 SMN 10317709 -500 tests 43797088 May25
- 2015 43819088 May25
- 2015 44098088 May25
- 2015 44623088 May 25
- 2015 45688089 June 22
- 2015 46661089 June 22
- 2015 48301090 August3
Distribution
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