GenetiSure Dx Labeling Kit recall: Labeling Error
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx…
Why was GenetiSure Dx Labeling Kit 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 05700571112601. REF/Lot: K1201-64105/0006798023, 5190-7317/0006793917
- Product
- GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx…
- Recalling firm
- Agilent Technologies, Inc.
- Quantity
- 70
- Distribution
- US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
- Recall date
- April 16, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)