---
title: "GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA fe... — FDA record Z-1544-2025 | Is It on Recall"
description: "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 m"
url: https://isitonrecall.com/recall/fda-device-z-1544-2025-genetisure-dx-labeling-kit-ref-k1201-64105-contains-human-reference-dna-female-aliquot-ref5190-7317/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required k... — FDA record Z-1544-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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).
- **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.
- **Classification**: Class II
- **Recalling firm**: Agilent Technologies, Inc.
- **Quantity**: 70
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1544-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1544-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Massachusetts](https://isitonrecall.com/state/massachusetts/)

## Dates in the source

- **Report date**: Apr 16, 2025
- **Recall initiation date**: Mar 20, 2025
- **Center classification date**: Apr 8, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1544-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Agilent Technologies, Inc. records](https://isitonrecall.com/brand/agilent-technologies-inc/)