BEUDAMED
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    BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code GGK·May 25, 2022

    MicroScan WalkAway-40 plus Instrument REF B1018-283

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    MicroScan WalkAway-96 plus Instrument REF B1018-284

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    DxM 1040 MicroScan WalkAway Instrument REF B1018-440

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    DxM 1096 MicroScan WalkAway Instrument REF B1018-496

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 2019

    MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code LRG·October 21, 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 Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 29, 2024

    Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code MMI·November 18, 2024

    Discrete photometric chemistry analyzer for clinical use.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 14, 2024

    Ringed DxI Reaction Vessels (RVs)

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 20, 2023

    Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·January 26, 2023

    Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code KHS·April 5, 2023

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·March 27, 2025

    Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code CEW·November 26, 2024

    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CGF·June 12, 2025

    DxI 9000 Access Immunoassay Analyzer, Part Number C11137

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JLW·September 19, 2025

    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code PER·September 8, 2025