Class II — Potential Health Hazard

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

Illumina NextSeq 550Dx Recalled by Illumina, Inc. Due to There is a potential that the DNA sequence...

Date: February 22, 2022
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

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

Quantity: 674 instruments

Why Was This Recalled?

There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.

Where Was This Sold?

This product was distributed to 31 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, LA, MD, MI, MN, NE, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV

Affected (31 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