Agilent recalls GenetiSure Dx Labeling Kit (REF K1201-64105) due to potential false test results from chromosome 12 shifts, risking delayed diagnosis of treatable genetic disorders.
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.
Agilent is recalling a DNA labeling kit used in genetic testing because a component may cause false positive or negative results, which could delay diagnosis and treatment of genetic conditions. This affects kits purchased for specific genetic tests.
The human reference DNA female aliquot in the kit has a mosaic chromosomal abnormality that can shift chromosome 12. This may cause false results in genetic tests, leading to delayed diagnosis and treatment of genetic conditions.
Users of the GenetiSure Dx Postnatal assay kit who purchased the specific labeling kit (REF K1201-64105) are affected. Those with genetic testing for treatable disorders are at most risk.
Check for the kit reference number K1201-64105 or lot number 0006798023. The product is sold for the GenetiSure Dx Postnatal assay (K1201A).
Verify the kit reference number K1201-64105 or lot number 0006798023 on the product.
The human reference DNA female aliquot has a mosaic chromosomal abnormality that may cause false positive or negative results in genetic tests, potentially delaying diagnosis and treatment of genetic conditions.
This recall means the kit could produce inaccurate results, which might delay diagnosis and treatment of a treatable genetic disorder. Contact your lab for guidance.
Check for the reference number K1201-64105 or lot number 0006798023 on the kit. The product is used with the GenetiSure Dx Postnatal assay (K1201A).
We’ve drafted a message you can send Agilent to request your refund or repair — edit it as you like.
Subject: Recall Z-1544-2025 — Agilent Agilent Hello, I own a Agilent that is covered by recall Z-1544-2025 from Agilent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
