FDA Recall: Cybersecurity Vulnerability of Software Used for Sequencing Instruments

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

PRODUCT

Recall Number:

REASON:

RECALLING FIRM/MANUFACTURER:

Illumina, Inc.

VOLUME OF PRODUCT IN COMMERCE:

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