Z-1544-2025Class II

GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A...

Name: Z-1544-2025 GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A...
Creator: Agilent Technologies, Inc.
Published: 2025-03-20
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2025-03-20 / Open, Classified / root cause: manufacturing process

FDA source

Agilent Technologies, Inc. began a recall of GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay... on 2025-03-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1544-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-20
Posted: 2025-04-08
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).
Product code: PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
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.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 70
Distribution: US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
Product codes and lots: UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1544-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-08

Product code PFX

K163367Class IIGenetiSure Dx Postnatal AssayAgilent Technologies, Inc. / cleared 2017-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)