ADVIA Centaur Tni-Ultra Assay — Class II medical device recall Z-2207-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2015-07-29, distributed nationwide. System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/A
| Recall number | Z-2207-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2015-05-19 |
| Classified | 2015-07-23 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2019-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, BH, CH, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IS, IT, JO, LB, LT, LU, LV, MA, MT, NL, NO, PK, PL, PT, QA, RO, RS, SA, SE, SI, SK, TN, TR |
| Reason classes | potency |
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/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
Reason for recall
System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.