Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NextSeq 550Dx Instrument Recalled by Illumina, Inc. Due to Cybersecurity vulnerability concerning the software used for sequencing...

Date: April 5, 2023
Company: Illumina, Inc.
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Illumina, Inc. directly.

Affected Products

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

Quantity: 1067 units

Why Was This Recalled?

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Illumina, Inc.

Illumina, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report