BEUDAMED
    FDA Enforcement Class II Ongoing

    GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).

    Recall: Z-1544-2025 · Reported April 16, 2025

    Enforcement

    Recall Number
    Z-1544-2025
    Event ID
    96484
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Agilent Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 16, 2025
    Initiation Date
    March 20, 2025
    Classification Date
    April 8, 2025
    Address
    5301 Stevens Creek Blvd, N/A, Santa Clara, CA, 95051-7201, United States

    Description

    GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).

    Reason

    DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.

    Code Info

    UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917

    Distribution

    US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland

    Quantity

    70