BEUDAMED
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    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·October 23, 2019

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·July 10, 2024

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 21, 2024

    UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 15, 2012

    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ¿ as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ¿ as an aid in the assessment of severity of congestive heart failure ¿ for the risk stratification of patients with acute coronary syndromes ¿ for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·July 2, 2014

    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·July 31, 2019

    ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·July 31, 2019

    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)

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014

    Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·December 19, 2012

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014

    ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 13, 2018

    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 Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·September 12, 2012

    Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.

    FDA Enforcement
    Class II ·Terminated·Alere San Diego, Inc.·May 14, 2014