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 | 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. |
| Product | Illumina NextSeq 550Dx, REF: 20005715, CE, IVD |
| Quantity | 674 instruments |
| 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 Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Ar… |
| Initiated | 2022-02-22 |
| Classified | 2022-03-31 |
| Recall number | Z-0854-2022 |
| 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-0854-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89699/
Alerts for Illumina, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.