Use caution Medical device recall · FDA · Published February 22, 2022

Illumina NextSeq 550Dx DNA Analyzer Recall: Short Circuit Risk

Illumina recalls NextSeq 550Dx DNA analyzers with potential short circuit after reconnection. Affected units have specific lot numbers and UDI codes. Stop using if device becomes inoperable.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0854-2022Medical device Illumina ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmIllumina, Inc.5200 Illumina Way · San Diego, CA 92122-4616

✎ GovInfoNow plain-language explainer

Illumina is recalling NextSeq 550Dx DNA analyzers that may short circuit after reconnection, causing the device to become inoperable. This could lead to equipment failure during DNA analysis work. Read more at govinfonow.com/recall/61120-illumina-nextseq-550dx-dna-analyzer-recall-short-circuit-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61120-illumina-nextseq-550dx-dna-analyzer-recall-short-circuit-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0854-2022

Cite this page

“Illumina NextSeq 550Dx DNA Analyzer Recall: Short Circuit Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61120-illumina-nextseq-550dx-dna-analyzer-recall-short-circuit-risk. Based on FDA recall #Z-0854-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0854-2022%22&limit=1).

The FDA announced on Feb. 22, 2022, that Illumina, Inc. is recalling 674 Illumina NextSeq 550Dx DNA sequence analyzers due to a potential short circuit hazard. The agency said the ribbon cable may be insufficiently reconnected, causing the device to become inoperable.

How to tell if you have it

Illumina NextSeq 550Dx
REF: 20005715, CE, IVD
Lot #s NDX550110 - NDX550843
UPC 00816270020125

The hazard

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

Context

GovInfoNow's records show Illumina, Inc. has had three other recalls since May 3, 2022, including a cybersecurity vulnerability recall on May 3, 2022, and another on April 5, 2023. Other recent recalls of similar products include the Illumina NextSeq 550Dx Reagent Kits recall (Oct. 28, 2025), the Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025), and the Edan iM20 Patient Monitor Recall (Oct. 24, 2025).

How to tell if you have this one

Check for lot numbers NDX550110 to NDX550843 on the device. The unique device identifier (UDI) starts with (01)00816270020125.

Brand
Illumina
Product
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Status
If the device becomes inoperable after reconnection, stop using it immediately.

Where it went and when

Where it was distributed

Distributed in 31 states, and outside the U.S.

FDA distribution: “US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Michigan, Minnesota, Nebraska, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 43 days after the firm started it.

Feb 22, 2022Firm started the recall
Mar 31, 2022FDA classified it Class II
Apr 6, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61120-illumina-nextseq-550dx-dna-analyzer-recall-short-circuit-risk">Illumina NextSeq 550Dx DNA Analyzer Recall: Short Circuit Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0854-2022 (February 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0854-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.