FDA Medical Device Recalls (openFDA)
Agilent Technologies, Inc.: 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 number
- Z-1544-2025
- Recalling firm
- Agilent Technologies, Inc.
- Product
- 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).
- Status
- Open, Classified
- Initiated
- 2025-03-20
- Posted
- 2025-04-08
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- 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 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
- 70
- Distribution
- US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
- Lot, serial or model codes
- UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917
- 510(k) numbers
- ["K163367"]
- PMA numbers
- not on file
- Product code
- PFX
- Firm FEI
- 2916205
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28