BEUDAMED
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    Filters FDA Recall × Status: Open, Classified × Clear all

    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

    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 (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

    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

    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PEP·February 15, 2022

    AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

    FDA Recall
    Open, Classified ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code OUG·March 8, 2023