ADVIA Centaur BNP Assay for in vitro diagnostic use in the… — Class III medical device recall Z-0229-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-11-26, distributed nationwide. Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ System
| Recall number | Z-0229-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2014-10-06 |
| Classified | 2014-11-19 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2015-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, IT, LT, LV, NL, NO, PL, PT, SI, SK, TR |
| Reason classes | labeling |
| Lot numbers | 038174, 100 |
| Model numbers | 02816138/SMN, 10309044 |
Product
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)
Reason for recall
Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.
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-0229-2015. 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.