FDA-Device2022-06-22Class II
illumina Model NextSeq 550 Dx REF 20005715
Illumina, Inc.
Hazard
cybersecurity vulnerability
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, Bulgaria, Bosnia/Herzegovina, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.
Affected count
799 instruments
Manufactured in
5200 Illumina Way, San Diego, CA, United States
Products
illumina Model NextSeq 550 Dx REF 20005715
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1260-2022Don't want to check this manually?
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