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Agilent Technologies, Inc. recalls GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit
Recalled April 16, 2025 · FDA recall Z-1544-2025 · Agilent Technologies
Hazard
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. · FDA Class II
Units
70
Sold at
US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
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 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.
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).
Manufacturer(s)
Agilent Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →