Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GenetiSure Dx Labeling Kit Recalled by Agilent Technologies, Inc. Due to DNA Labeling Kit for use in sample labeling...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Agilent Technologies, Inc. directly.
Affected Products
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).
Quantity: 70
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: MA
About Agilent Technologies, Inc.
Agilent Technologies, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report