FDA-Device2023-06-28Class II
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service 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
1067 units
Manufactured in
5200 Illumina Way, San Diego, CA, United States
Products
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief