Z-1976-2023 Class II

Recalled by Illumina, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
June 28, 2023
Initiation Date
April 5, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1067 units

Product Description

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

Reason for Recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

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.

Code Information

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