Test, Natriuretic Peptide
Clinical Chemistry · 21 CFR 862.1117
Recent MDR events
467 adverse event reports on file
- ELECSYS PROBNP IIJun 22, 2026MalfunctionRoche Diagnostics1823260-2026-02474
- ELECSYS PROBNP IIApr 27, 2026MalfunctionRoche Diagnostics1823260-2026-01610
- ELECSYS PROBNP IIApr 27, 2026MalfunctionRoche Diagnostics1823260-2026-01638
- VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACKApr 24, 2026MalfunctionOrtho-clinical Diagnostics, Inc.3007111389-2026-00077
- ELECSYS PROBNP IIApr 2, 2026MalfunctionRoche Diagnostics1823260-2026-01240
- ACCESS B-TYPE NATRIURETIC PEPTIDEMar 30, 2026InjuryBeckman Coulter, Inc2122870-2026-00007
- ELECSYS PROBNP IIMar 30, 2026MalfunctionRoche Diagnostics1823260-2026-01136
- ELECSYS PROBNP IIMar 26, 2026MalfunctionRoche Diagnostics1823260-2026-01108
- VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACKFeb 9, 2026MalfunctionOrtho-clinical Diagnostics, Inc.3007111389-2026-00030
- VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACKFeb 9, 2026MalfunctionOrtho-clinical Diagnostics, Inc.3007111389-2026-00029
Event type breakdown
Recalls
22 recall events for this product code
- Biomerieux France Chemin De L'OrTerminatedSep 10, 2016
VIDAS NT-pro-BNP
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Z-2779-2016 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedJan 7, 2016
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Z-0610-2016 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedJun 26, 2015
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test
Complaints of failed calibration.
Z-2149-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedJun 26, 2015
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test
Complaints of failed calibration.
Z-2150-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedNov 19, 2014
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 Centau
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.
Z-0229-2015 · View FDA record ↗ - Alere San Diego, Inc.TerminatedJun 26, 2014
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202
Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.
Z-1928-2014 · View FDA record ↗ - Alere San Diego, Inc.TerminatedMay 2, 2014
Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BN
These lots may not recover within range when tested using certain commercially available controls.
Z-1540-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedDec 11, 2012
Siemens Healthcare BNP (8-type Natriuretic Peptide)
Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Z-0506-2013 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedSep 6, 2012
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Ce
Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
Z-2313-2012 · View FDA record ↗ - Abbott Point Of Care Inc.TerminatedAug 9, 2012
i-Stat BNP cartridges
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Z-2170-2012 · View FDA record ↗
Registered firms
75 firms currently registered for this product code
Diamond Diagnostics Inc.
Budapest, HU
Tosoh Aia, Inc.
TOYAMA, JP
Tosoh Bioscience, Inc.
Grove City, OH, US
Quidel Cardiovascular Inc.
San Diego, CA, US
Nano-ditech Corporation
Cranbury, NJ, US
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Abbott Point Of Care Canada Limited
Ottawa Ontario, CA
Response Biomedical Corp.
Vancouver British Columbia, CA
Tosoh Corp.
Chuo-ku Tokyo, JP
Beckman Coulter, Inc.
CHASKA, MN, US
Fujirebio Diagnostics, Inc.
Malvern, PA, US
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, Llc.
CORTLANDT MANOR, NY, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Acro Biotech Inc.
Montclair, CA, US
510(k) clearances
45 clearances for this product code
- Beckman Coulter, Inc.Mar 24, 2026
K252169 · Access BNP II
- Axis-Shield Diagnostics, Ltd.Feb 18, 2026
K253539 · Alere NT-proBNP for Alinity i
- Axis-Shield Diagnostics, Ltd.Jan 16, 2025
K241176 · Alere NT-proBNP for Alinity i Reagent Kit
- Beckman Coulter, Inc.Apr 12, 2024
K232164 · Access NT-proBNP
- Siemens Healthcare Diagnostics, Inc.Sep 24, 2023
K220265 · ADVIA Centaur® NT-proBNPII (PBNPII)
- Roche DiagnosticsJul 21, 2023
K223637 · Elecsys proBNP II, Elecsys proBNP II STAT
- Roche DiagnosticsMar 31, 2022
K210546 · Elecsys proBNP II, Elecsys proBNP II STAT
- Tosoh Bioscience, Inc.Nov 8, 2021
K211199 · ST AIA-PACK BNP Assay