Reagent Kits/ containing flow cells — Class II medical device recall Z-0884-2026
Ongoing recall by Illumina, Inc., reported 2025-12-10, distributed nationwide. An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits
| Recall number | Z-0884-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Illumina, Inc., San Diego, CA, United States |
| Recall initiated | 2025-10-28 |
| Classified | 2025-12-04 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 11,916 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00816270020118, 00816270020125, 00816270020132 |
| Lot numbers | A179804-3, A182051-3, A182298-3, A182299-3, A182301-3, A182302-3, A182413-3, A182532-3, A182533-3, A182816-3, A183118-3, A183170-4, A183211-3, A183278-4, A183279-4, A183339-3, A183404-4, A183405-4, A183409-4, A183449-3, A183555-4, A183568-4, A183569-4, A183570-4, A183612-3, A183613-3, A183826-3, A183830-3, A183950-3, A183951-3, A184058-3, A184359-3, A184531-3, A185016-3 |
| Model numbers | 15050205, 20026365, 20028870/NEXTSEQ, 20028871/NEXTSEQ, 20031098, 20062316, 20062530, 20064341/CN, 20064344/CN, 550DXHO |
Product
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205
Reason for recall
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0884-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.