PlainRecalls
FDA Devices Moderate Class II Completed

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

Reported: June 28, 2023 Initiated: April 5, 2023 #Z-1977-2023

Product Description

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

Reason for Recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Details

Recalling Firm
Illumina, Inc.
Units Affected
740 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?
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.. Recalled by Illumina, Inc.. Units affected: 740 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-1977-2023.