FDA Device recall Z-1977-2023
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software
- FDA Device
- Class II
- completed
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class II recall of MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) 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-1977-2023 |
| 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
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Reason
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Identifiers
| code_info | UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Other recalls by Illumina
- NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232
FDA Device · Class II · 2026-10-07 · Illumina - Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, RE…
FDA Device · Class II · 2025-12-10 · Illumina - NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Device · Class II · 2023-06-28 · Illumina - illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
FDA Device · Class II · 2022-06-22 · Illumina - illumina Model NextSeq 550 Dx REF 20005715
FDA Device · Class II · 2022-06-22 · Illumina
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1977-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.