GenetiSure Dx Labeling Kit, REF: K1201-64105, contains… recallZ-1544-2025 · Agilent Technologies, Inc. · initiated Mar 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Agilent Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1544-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 20, 2025
- Posted by the FDA
- Apr 8, 2025
- Recalling firm
- Agilent Technologies, Inc.
- Quantity
- 70
- Product code
- PFX
- FDA submissions
- K163367
- Distribution
- US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
Product 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).
Code information (models, lots, serial numbers)
UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GenetiSure Dx Labeling Kit K1201-64105Agilent Technologies, Inc. · System, microarray-based, genome-wide, postnatal chromosomal abnormality detection1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page