BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated March 20, 2025

    Recall

    Recall Number
    Z-1544-2025
    Event Number
    96484
    Firm
    Agilent Technologies, Inc.
    FEI Number
    2916205
    Product Code
    PFX
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 20, 2025
    Posted
    April 8, 2025
    Address
    5301 Stevens Creek Blvd, Santa Clara, CA, 95051-7201

    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.

    Action

    On 3/20/2025, "URGENT MEDICAL DEVICE RECALL" notices dated 3/20/2025 were emailed to customers who were asked to do the following: 1. Please check your inventory and identify if you have the affected product. 2. Confirm the number of affected kits in your possession and discard any unused kits. 3. Inform those who need to be aware of this notification within your organization or any other organization to which the affected product(s) have been transferred. Please ensure that your organization maintains awareness of this notice. 4. Complete and return the acknowledgement form via email to [email protected] This issue is limited only to chromosome 12, and the data generated can be analyzed using the CytoDx functionalities by displaying the moving average line in the Genome View, Chromosome View, or Gene View of the Triage View. If you have any questions, contact Agilent Technologies, Inc. via email: [email protected] or call 408-386-7294.

    Distribution

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

    Quantity

    70