The U.S. Food and Drug Administration (FDA) is informing health care providers and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service (UCS) software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments. These instruments are medical devices that may be specified either for clinical diagnostic use in sequencing a person’s DNA for various genetic conditions or for research use only (RUO).
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