# FDA recall Z-1544-2025

> **Agilent Technologies, Inc.** · Class II · device recall initiated 2025-03-20.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1544-2025
- **Recalling firm:** Agilent Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-20
- **Report date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1544-2025

## Citation

> AI Analytics. FDA recall Z-1544-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1544-2025. Source: US FDA. Licensed CC0.

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