Device recall
Z-0884-2026: Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument…
FDA device recall · Class II · Illumina, Inc.
Key facts
| Recall number (Z-number) | Z-0884-2026 |
|---|---|
| Recall event | 97913 |
| 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… |
| Product code | PFT |
| Recalling firm | Illumina, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3003218906 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database