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Agilent Technologies, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Agilent Technologies, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-04-16FDA-DeviceClass IIGenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
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.
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