FDA Medical devices recall ·
GenetiSure Dx Labeling Kit recall
- Recall number
- Z-1544-2025
- Date
- (initiated March 20, 2025)
- Company / brand
- Agilent Technologies, Inc.
5301 Stevens Creek Blvd, Santa Clara, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 70
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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).
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917
Distribution
US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
States: Massachusetts
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1544-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.