illumina Model NextSeq 550 Dx REF 20005715
Medical device recall Z-1260-2022. Published in FDA’s Enforcement Report on Jun 22, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 22, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Completed its status, in FDA’s file
- Nationwide FDA’s word, and 43 states named
- 799 instruments how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
cybersecurity vulnerability
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
illumina Model NextSeq 550 Dx REF 20005715
799 instruments, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: 20005715 UDI-DI Code: 00816270020125 All Instruments containing Local Run Manager (LRM) Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: NDX550779-15073937 NDX550504-15073937 NDX550732-15073937 NDX550287-15073937…
Every code shown here, 1,987 characters
Model Numbers: 20005715 UDI-DI Code: 00816270020125 All Instruments containing Local Run Manager (LRM) Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: NDX550779-15073937 NDX550504-15073937 NDX550732-15073937 NDX550287-15073937 NDX550802-15073937 NDX550691-15073937 NDX550656-15073937 NDX550725-15073937 NDX550736-15073937 NDX550754-15073937 NDX550151-15073937 NDX550996-15073937 NDX550916-15073937 NDX550420-15073937 NDX550715-15073937 NDX550726-15073937 NDX550729-15073937 NDX550730-15073937 NDX550712-15073937 NDX550722-15073937 NDX550660-15073937 NDX550603-15073937 NDX550601-15073937 NDX550595-15073937 NDX550553-15073937 NDX550568-15073937 NDX550579-15073937 NDX550586-15073937 NDX550590-15073937 NDX550561-15073937 NDX550522-15073937 NDX550535-15073937 NDX550563-15073937 NDX550485-15073937 NDX550547-15073937 NDX550552-15073937 NDX550560-15073937 NDX550537-15073937 NDX550531-15073937 NDX550532-15073937 NDX550533-15073937 NDX550501-15073937 NDX550503-15073937 NDX550474-15073937 NDX550445-15073937 NDX550432-15073937 NDX550378-15073937 NDX550369-15073937 NDX550374-15073937 NDX550115-15073937 NDX550370-15073937 NDX550376-15073937 NDX550381-15073937 NDX550361-15073937 NDX550257-15073937 NDX550313-15073937 NDX550288-15073937 15073937NDX550261 NDX550207-15073937 NDX550149-15073937 NDX550138-15073937 NDX550123-15073937 NDX550105-15073937 NDX550136-15073937 NDX550140-15073937 NDX550914-15073937 NDX550968-15073937 NDX550851-15073937 NDX550962-15073937 NDX550763-15073937 NDX550572-15073937 NDX550276-15073937 NDX550389-15073937 NDX550399-15073937 NDX550409-15073937 NDX550414-15073937 NDX550425-15073937 NDX550427-15073937 NDX550348-15073937 NDX550353-15073937 NDX550337-15073937 NDX550338-15073937 NDX550804-15073937 NDX550365-15073937 NDX550839-15073937 NDX550621-15073937 NDX550490-15073937 NDX550580-15073937 NDX550611-15073937 NDX550608-15073937 NDX550594-15073937 NDX550430-15073937 NDX550385-15073937 NDX550310-15073937 NDX550241-15073937 NDX550201-15073937…
FDA’s list runs to 15,559 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, Bulgaria, Bosnia/Herzegovina, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.
The states and territories these words name
43 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Completed, in FDA’s file.
“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”
openFDA, on “Completed”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 3, 2022.
- FDA classified it on Jun 13, 2022.
- FDA’s Enforcement Report published it on Jun 22, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Illumina, Inc., of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 15,559 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.