Class II — Illumina, Inc.
| Recalling firm | Illumina, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| Reason | cybersecurity vulnerability |
| Product | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx |
| Quantity | 1,014 instruments |
| Distribution | 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, Eg… |
| Initiated | 2022-05-03 |
| Classified | 2022-06-13 |
| Recall number | Z-1259-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Illumina, Inc. (Z-1259-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90160/
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