Illumina, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1977-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 5, 2023

Date Posted: June 28, 2023

Recall Number: Z-1977-2023

Event ID: 92233

Reason for Recall:

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Status: Completed

Product Quantity: 740 units

Code Information:

UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002

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.

Voluntary or Mandated:

Voluntary: Firm initiated