BEUDAMED
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    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Ireland, Inc.·December 31, 2025

    Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 12, 2017

    Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 21, 2018

    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.

    FDA Enforcement
    Class II ·Terminated·Normand Informatique·December 20, 2017

    Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·July 12, 2017

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 30, 2025

    Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 4, 2015

    Beckman Coulter, Lactate Assay, Catalog No. OSR6X93

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 4, 2015

    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 4, 2015

    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·May 24, 2023

    Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·May 24, 2023

    Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·May 24, 2023

    Beckman Coulter Lipase, REF OSR6130 and OSR6230.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 30, 2019

    Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·March 27, 2013

    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 4, 2015

    SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·November 12, 2025

    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 15, 2016

    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·January 11, 2023

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

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·January 31, 2024

    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 15, 2016