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NovaSeq™ 6000Dx Library Tube, 24 pack

ILLUMINA, INC. · Model 20062291 · UDI-DI 00816270020583

PFT Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
14
Facilities

Description

The Illumina NovaSeq™ 6000Dx Library Tubes, 24 pack are intended to hold sample libraries for sequencing with NovaSeq™ 6000Dx S2 or S4 reagent kits and validated assays. The tubes are boxed together in one box, 20060177, NovaSeq™ 6000Dx Library Tubes Pk, which is labeled with the same Device Identifier.

Recalls

DateFirmReason
2025-10-28Illumina, 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
2018-04-26Horiba Instruments, Inc dba Horiba MedicalWhen 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

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Data 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.