medical Class II Updated 2025-04-16

Agilent Technologies, Inc. recalls GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human

Recalled 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).


Hazard / Issue

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.

Issued by

FDA

Affected States: MA
Lot/Code Info: UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917
View official government recall

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