BEUDAMED
    8 results · 57ms · Sources: EU EUDAMED, US FDA

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    MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).

    FDA Recall
    Terminated ·DiaSorin Molecular LLC·Product code PLO·May 12, 2020

    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.

    FDA Recall
    Terminated ·DiaSorin Molecular LLC·Product code OQO·May 12, 2020

    SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code QJR·September 23, 2021

    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code QJR·January 30, 2023

    MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.

    FDA Recall
    Terminated ·DiaSorin Molecular LLC·Product code PGI·May 12, 2020

    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OOI·November 19, 2021

    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OCC·January 30, 2023

    Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OOI·June 14, 2023