# FDA recall Z-1977-2023

> **Illumina, Inc.** · Class II · device recall initiated 2023-04-05.

## Product

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

## Reason for recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

## 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.

## Key facts

- **Recall number:** Z-1977-2023
- **Recalling firm:** Illumina, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-04-05
- **Report date:** 2023-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1977-2023

## Citation

> AI Analytics. FDA recall Z-1977-2023. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1977-2023. Source: US FDA. Licensed CC0.

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