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U.S. Department of Health and Human Services

Class 2 Device Recall GenetiSure Dx Labeling Kit

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 Class 2 Device Recall GenetiSure Dx Labeling Kitsee related information
Date Initiated by FirmMarch 20, 2025
Date PostedApril 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1544-2025
Recall Event ID 96484
510(K)NumberK163367 
Product Classification System, microarray-based, genome-wide, postnatal chromosomal abnormality detection - Product Code PFX
ProductGenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
Code Information UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917
FEI Number 2916205
Recalling Firm/
Manufacturer		 Agilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara CA 95051-7201
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 fieldactions@agilent.com 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: andrea.topper@agilent.com or call 408-386-7294.
Quantity in Commerce70
DistributionUS distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PFX
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