FDA Recall: Cybersecurity Vulnerability of Software Used for Sequencing Instruments

Company: Illumina, Inc.
Date of Enforcement Report: 06/16/2023
Class II

PRODUCT

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

Recall Number:

Z-1976-2023

REASON:

Cybersecurity vulnerability concerning the software used for sequencing instruments.

RECALLING FIRM/MANUFACTURER:

Illumina, Inc.

VOLUME OF PRODUCT IN COMMERCE:

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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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