illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model:…
Medical device recall Z-1259-2022. 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
- 1,014 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 REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
1,014 instruments, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: DX-410-1001; 15036706; 20014053; UDI-DI Code: 00816270020002 00816270020699 All Instruments containing Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: M71006-20014737 M70955-20014737 M70992-20014737…
Every code shown here, 1,987 characters
Model Numbers: DX-410-1001; 15036706; 20014053; UDI-DI Code: 00816270020002 00816270020699 All Instruments containing Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: M71006-20014737 M70955-20014737 M70992-20014737 M70999-20014737 M70957-20014737 M70989-20014737 M70983-20014737 M70979-20014737 M70971-20014737 M70977-20014737 M70968-20014737 M70938-20014737 M70951-20014737 M70770-20014737 M70956-20014737 M70958-20014737 M70946-20014737 M70939-20014737 M70922-20014737 M70905-20014737 M70932-20014737 M70904-20014737 M70925-20014737 M70894-20014737 M70906-20014737 M70892-20014737 M70899-20014737 M70897-20014737 M70865-20014737 M70882-20014737 M70879-20014737 M70883-20014737 M70868-20014737 M70880-20014737 M70878-20014737 M70864-20014737 M70858-20014737 M70861-20014737 M70797-20014737 M70842-20014737 M70843-20014737 M70855-20014737 M70848-20014737 M70840-20014737 M70826-20014737 M70818-20014737 M70822-20014737 M70827-20014737 M70815-20014737 M70296-15037414 M70813-20014737 M70814-20014737 M70810-20014737 M70799-20014737 M70809-20014737 M70803-20014737 M70804-20014737 M70805-20014737 M70806-20014737 M70808-20014737 M70807-20014737 M70767-20014737 M70795-20014737 M70789-20014737 M70790-20014737 M70792-20014737 M70793-20014737 M70784-20014737 M70791-20014737 M70794-20014737 M70742-20014737 M70723-20014737 M70781-20014737 M70776-20014737 M70778-20014737 M70779-20014737 M70773-20014737 M70739-20014737 M70774-20014737 M70744-20014737 M70771-20014737 M70777-20014737 M70750-20014737 M70753-20014737 M70769-20014737 M70761-20014737 M70765-20014737 M70554-20014737 M70745-20014737 M70746-20014737 M70747-20014737 M70748-20014737 M70749-20014737 M70551-20014737 M70754-20014737 M70755-20014737 M70743-20014737 M70741-20014737 M70721-20014737 M70733-20014737 M70731-20014737 M70728-20014737 M70732-20014737 M70729-20014737 M70730-20014737 M70725-20014737 M70724-20014737 M70726-20014737 M70715-20014737 M70713-20014737 M70707-20014737 M70710-20014737 M70714-20014737…
FDA’s list runs to 16,198 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 16,198 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.