Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay — Class II medical device recall Z-2041-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-06-29, distributed nationwide. Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instru
| Recall number | Z-2041-2016 |
|---|---|
| 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 | 2016-05-02 |
| Classified | 2016-06-20 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2018-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, CA, CH, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HR, HU, IS, IT, LT, LU, LV, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, TN, TR |
| Model numbers | 02789602/SMN, 02790309/SMN, 1031, 10317709, 7708 |
Product
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin 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 Cat No. 02789602/SMN 1031 7708 (100 test) Cat No. 02790309/SMN 10317709 (500 test)
Reason for recall
Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2041-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.