BEUDAMED
    95 results · 22ms · Sources: EU EUDAMED, US FDA

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    Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CEW·November 8, 2024

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·September 12, 2023

    DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·April 18, 2024

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 5, 2025

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·December 5, 2018

    Ringed DxI Reaction Vessels (RVs)

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

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 6, 2025

    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code CFP·November 21, 2023

    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·November 21, 2023

    DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·March 5, 2024

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·November 13, 2024

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

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

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

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

    DxI 9000 Access Immunoassay Analyzer C11137

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 7, 2025

    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

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

    DxI 9000 Access Immunoassay Analyzer, Part Number C11137

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

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·July 10, 2024

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

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

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