FDA Device recall Z-1260-2022
illumina Model NextSeq 550 Dx REF 20005715
- FDA Device
- Class II
- completed
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of illumina Model NextSeq 550 Dx REF 20005715 by Illumina, citing cybersecurity vulnerability.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1260-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-05-03 |
| Published | 2022-06-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Illumina |
| Distribution | US |
Product
illumina Model NextSeq 550 Dx REF 20005715
Reason
cybersecurity vulnerability
Identifiers
| code_info | Model Numbers: 20005715 UDI-DI Code: 00816270020125 All Instruments containing Local Run Manager (LRM) Software versi…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 NDX550474-150739 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1260-2022%22
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