FDA Device recall Z-1259-2022
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
- FDA Device
- Class II
- completed
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx by Illumina, citing cybersecurity vulnerability.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1259-2022 |
| 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 REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
Reason
cybersecurity vulnerability
Identifiers
| code_info | Model Numbers: DX-410-1001; 15036706; 20014053; UDI-DI Code: 00816270020002 00816270020699 All Instruments containing…Model Numbers: DX-410-1001; 15036706; 20014053; UDI-DI Code: 00816270020002 00816270020699 All Instruments containing Software version: v.1.3.1 to 3.0 Installed Product ID: U.S.: M71006-20014737 M70955-20014737 M70992-20014737 M70999-20014737 M70957-20014737 M70989-20014737 M70983-20014737 M70979-20014737 M70971-20014737 M70977-20014737 M70968-20014737 M70938-20014737 M70951-20014737 M70770-20014737 M70956-20014737 M70958-20014737 M70946-20014737 M70939-20014737 M70922-20014737 M70905-20014737 M70932-20014737 M70904-20014737 M70925-20014737 M70894-20014737 M70906-20014737 M70892-20014737 M70899-20014737 M70897-20014737 M70865-20014737 M70882-20014737 M70879-20014737 M70883-20014737 M70868-20014737 M70880-20014737 M70878-20014737 M70864-20014737 M70858-20014737 M70861-20014737 M70797-20014737 M70842-20014737 M70843-20014737 M70855-20014737 M70848-20014737 M70840-20014737 M70826-20014737 M70818-20014737 M70822-20014737 M70827-20014737 M70815-20014737 M70296-15037414 M70813-20014737 M7 |
|---|
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 - MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software
FDA Device · Class II · 2023-06-28 · Illumina - NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Device · Class II · 2023-06-28 · 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-1259-2022%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.