Reported Apr 16, 2025 · Ongoing
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit…
Agilent Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Agilent Technologies, Inc. · 5301 Stevens Creek Blvd · Santa Clara, CA · 95051-7201
Is this the product you have?
- GenetiSure Dx Labeling Kit
- REFK1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A)
- Lot codes and dates
- UDI-DI05700571112601
- REF/Lot
K1201-64105/00067980235190-7317/0006793917
- Amount recalled
- 70
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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