FDA Device recall Z-0229-2015
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma u…
- FDA Device
- Class III
- terminated
- Published 2014-11-26
On 2014-11-26 the FDA classified a Class III recall of ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma u… by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable si….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0229-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2015%22
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