FDA Device recall Z-1976-2023
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
- FDA Device
- Class II
- completed
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class II recall of NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software by Illumina, citing cybersecurity vulnerability concerning the software used for sequencing instruments.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1976-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-04-05 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Illumina |
| Distribution | US |
Product
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Reason
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Identifiers
| code_info | Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125 |
|---|
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-1976-2023%22
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