FDA-Device2023-06-28Class II
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Illumina, Inc.
Hazard
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Sold states
Worldwide distribution - US Nationwide and the countries of Algeria, AU Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, FR France, GB Georgia, Germany, Guatemala, Hong Kong, Hungary, IT Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Fed., Saudi Arabia, SG Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd. Arab Emir., Vietnam, Argentina, Aerbaijan, Belgium, Bosnia-Herz., Finland, Greece, Iceland, Ireland, Israel, Japan, Nigeria, NL Norway, Romania, Serbia, Slovakia, South Africa, T¿rkiye, Ukraine.
Affected count
740 units
Manufactured in
5200 Illumina Way, San Diego, CA, United States
Products
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1977-2023Don't want to check this manually?
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