Home › ILLUMINA, INC. › NovaSeq™ 6000Dx Library Tube
NovaSeq™ 6000Dx Library Tube
ILLUMINA, INC. · Model 20062290 · UDI-DI 00816270020552
PFT
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities
Description
The Illumina NovaSeq™ 6000Dx Library Tube is intended to hold sample libraries for sequencing with NovaSeq 6000Dx S2 or S4 reagent kits and validated assays. The tube is boxed in one box, 20046942, NovaSeq™ 6000Dx Library Tube, which is labeled with the same Device Identifier.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-28 | Illumina, Inc. | 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 i |
| 2018-04-26 | Horiba Instruments, Inc dba Horiba Medical | When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.