FDA Device recall Z-0854-2022
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- FDA Device
- Class II
- completed
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Illumina NextSeq 550Dx, REF: 20005715, CE, IVD by Illumina, citing 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 reconn….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0854-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-02-22 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Illumina |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, NC, NE, NJ, NM, NY, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV |
Product
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
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.
Identifiers
| code_info | Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125 |
|---|
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 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0854-2022%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.