BEUDAMED
    FDA Enforcement Class II Ongoing

    RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

    Recall: Z-0200-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0200-2024
    Event ID
    93102
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2023
    Initiation Date
    September 6, 2023
    Classification Date
    October 31, 2023
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

    Reason

    RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

    Code Info

    GTIN: 05055273206104 Lot/Batch Number: (1) 7201-0747 7201-0423 7201-0417 7201-0353 7255-0198 7255-0172 7255-0171 7255-0129 7201-1085 7201-1086 7201-1079 7201-1080 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0482 (2)¿¿¿¿¿¿¿¿¿¿¿¿¿ 7201-0776 7201-0367 7201-0343¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ 7201-0348 ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿

    Distribution

    US Nationwide distribution including Puerto Rico

    Quantity

    35 units