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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Illumina, Inc.
Reason for Recall:
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1976-2023

Related Recalls

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

Oct 28, 2025 Diagnostic Equipment Nationwide View Details →