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    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 Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·October 6, 2014

    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 Recall
    Terminated ·Abbott Laboratories·Product code JIT·May 24, 2019

    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 Recall
    Terminated ·Abbott Point Of Care Inc.·Product code NBC·February 1, 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 Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·May 30, 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 Recall
    Terminated ·Abbott Laboratories·Product code JJX·May 24, 2019

    DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right, Depuy, Warsaw, IN; REF DNPAR. The device is used in the treatment of fractures and osteotomies of the distal radius.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HRS·December 23, 2008

    DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS. The device is used in the treatment of fractures and osteotomies of the distal radius.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HRS·December 23, 2008

    DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF DNPAL. The device is used in the treatment of fractures and osteotomies of the distal radius.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HRS·December 23, 2008

    DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJIG. The device is used in the treatment of fractures and osteotomies of the distal radius.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HRS·December 23, 2008

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·July 25, 2012

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·June 23, 2014

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·June 23, 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 Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·November 14, 2012

    The Quidel Triage BNP Calibrators

    FDA Recall
    Terminated ·Medline Industries Inc·Product code NBC·October 1, 2020

    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HRS·June 23, 2014

    Control, Calibrator Verified, Triage BNP, Model ALR88755

    FDA Recall
    Terminated ·Medline Industries Inc·Product code JJY·July 28, 2020

    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 Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·March 20, 2014

    i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·January 1, 2008

    The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.

    FDA Recall
    Terminated ·Randox Laboratories 55 The Diamond Road Antrim United Kingdom·Product code JJY·September 16, 2016

    ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code PPM·December 19, 2017