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Recall Observatory FDA recall evidence

Device product

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

Z-1976-2023

April 05, 2023

Class II

Product summary

Firm
Illumina, Inc.
Event
Event 92233
Status
Completed
Classification
Class II
Quantity
1067 units
Official record key
device-enforcement:Z-1976-2023

Official wording

Reason: Cybersecurity vulnerability concerning the software used for sequencing instruments.

Code information: Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Cybersecurity vulnerability