DNA Labeling Kit Component Affected by Chromosome Aberration
Agilent's GenetiSure Dx Labeling Kit contains a human reference DNA component with a mosaic aberration that may cause false test results and diagnosis delays in genetic testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source is classified FDA Class II and involves a high-risk diagnostic error (false positive/negative results) with potential for patient harm through diagnosis delay and delayed treatment of treatable genetic disorders. No reported illnesses are mentioned, but the risk of significant harm is inherent to the defect.
Plain-English summary
Agilent Technologies is recalling the GenetiSure Dx Labeling Kit (REF: K1201-64105), which includes a human reference DNA female aliquot (REF: 5190-7317). The kit is a required component for the GenetiSure Dx Postnatal assay and is used for sample labeling in oligonucleotide microarray testing.
The recall is due to a mosaic aberration affecting the human reference DNA component. This aberration may result in a Chromosome 12 baseline shift during testing, which could lead to false positive or negative results in genetic diagnoses.
False or delayed test results may lead to diagnosis delays and postponed treatment of treatable genetic disorders. The affected product was distributed to Massachusetts and internationally to Spain, Italy, Japan, Colombia, and Poland. Approximately 70 units were affected.
Users of this kit should contact Agilent Technologies for guidance on affected lot numbers K1201-64105/0006798023 and 5190-7317/0006793917 (UDI-DI: 05700571112601) and any remedial actions needed.
The recalled product
- 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
- Agilent Technologies, Inc.
- Hazard
- diagnostic-error
- false-results
- chromosome-aberration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023
- 5190-7317/0006793917
Distribution
Distributed in 1 state:
- MA
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