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    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 25, 2025

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

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 25, 2025

    UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 25, 2025

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

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 25, 2025

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

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 25, 2025

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

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 25, 2025

    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 Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 29, 2024

    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 Recall
    Terminated ·OrthoPediatrics Corp·Product code HSB·August 19, 2019

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·October 1, 2025

    Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·October 1, 2025

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

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 22, 2024

    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

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

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NBC·December 18, 2017

    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

    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·December 18, 2017

    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