GenetiSure Dx Labeling Kit — Class II medical device recall Z-1544-2025
Ongoing recall by Agilent Technologies, Inc., reported 2025-04-16. DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, H
| Recall number | Z-1544-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agilent Technologies, Inc., Santa Clara, CA, United States |
| Recall initiated | 2025-03-20 |
| Classified | 2025-04-08 |
| Reported by FDA | 2025-04-16 |
| Countries outside the US | CO, ES, IT, JP, PL |
| Quantity | 70 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05700571112601 |
| Lot numbers | 5190-7317/0006793917, K1201-64105/0006798023 |
| Model numbers | 5190-7317, K1201-64105 |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1544-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.