BEUDAMED
    6 results · 35ms · Sources: EU EUDAMED, US FDA

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    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

    FDA Enforcement
    Class II ·Completed·Beckman Coulter, Inc.·July 23, 2025

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

    FDA Enforcement
    Class II ·Completed·Beckman Coulter, Inc.·February 12, 2025

    AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Inc.·March 28, 2018

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

    FDA Recall
    Completed ·Beckman Coulter, Inc.·Product code JJE·January 3, 2024

    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

    FDA Recall
    Completed ·Beckman Coulter, Inc.·Product code CDD·February 27, 2025

    AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255

    FDA Recall
    Completed ·Beckman Coulter Inc.·Product code JQP·January 19, 2018