Agilent Technologies is recalling approximately 70 GenetiSure Dx Labeling Kits (REF: K1201-64105) due to a defect in one of the kit components. The Human Reference DNA Female aliquot inside the kit may contain a genetic aberration that causes errors during laboratory testing. This defect can lead to incorrect or delayed results when testing for genetic disorders. No injuries or incidents have been reported to date.
The genetic aberration in the kit can cause a baseline shift in Chromosome 12 analysis, potentially leading to false positive or false negative test results. This may cause a patient to receive an incorrect medical diagnosis or experience a delay in receiving treatment for a genetic disorder.
A required kit for the GenetiSure Dx Postnatal assay (K1201A). Contains human reference DNA female aliquot (REF 5190-7317).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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