BEUDAMED
    9 results · 49ms · Sources: EU EUDAMED, US FDA

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    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·March 24, 2026

    FoundationOne Companion Diagnostic (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·February 15, 2023

    FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·November 8, 2022

    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·March 20, 2026

    FoundationOne Companion Diagnostic (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·April 9, 2025

    FoundationOne CDx (F1CDx), RAL-0003 version 31.0

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·November 8, 2022

    FoundationOne Companion Diagnostic (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·June 18, 2024

    FoundationOne CDx test report

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·August 8, 2019

    FoundationOne CDx Test Results

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·October 31, 2018