PlainRecalls
FDA Devices Moderate Class II Completed

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

Reported: June 28, 2023 Initiated: April 5, 2023 #Z-1976-2023

Product Description

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

Reason for Recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Details

Recalling Firm
Illumina, Inc.
Units Affected
1067 units
Distribution
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.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software. Recalled by Illumina, Inc.. Units affected: 1067 units.
Why was this product recalled?
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 28, 2023. Severity: Moderate. Recall number: Z-1976-2023.