BEUDAMED
    FDA Enforcement Class II Ongoing

    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004

    Recall: Z-2425-2024 · Reported July 31, 2024

    Enforcement

    Recall Number
    Z-2425-2024
    Event ID
    94858
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 31, 2024
    Initiation Date
    June 7, 2024
    Classification Date
    July 24, 2024
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004

    Reason

    Cystatin C Reagent marketed without a 510 (k)

    Code Info

    GTIN: 05055273208665 All lots

    Distribution

    US Nationwide distribution in the states of AL, CA, GA, NY.

    Quantity

    115 kits