Agilent Technologies, Inc.: Device Recall
Recall #Z-1544-2025 · 03/20/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1544-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Agilent Technologies, Inc.
- Status
- Ongoing
- Date Initiated
- 03/20/2025
- Location
- Santa Clara, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70
Reason for Recall
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 Description
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).
Distribution Pattern
US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.