BEUDAMED
    FDA Enforcement Class II Ongoing

    IRON assay, Reference Numbers 6K95-41 and 6K95-30

    Recall: Z-0325-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0325-2024
    Event ID
    93298
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sentinel CH SpA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2023
    Initiation Date
    September 29, 2023
    Classification Date
    November 17, 2023
    Address
    Via Robert Koch 2, N/A, Milan, N/A, N/A, Italy

    Description

    IRON assay, Reference Numbers 6K95-41 and 6K95-30

    Reason

    A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

    Code Info

    Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    4394 kits