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Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)

ILLUMINA, INC. · Model 20051355 · UDI-DI 00816270020484

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from peripheral whole blood and formalin-fixed, paraffin-embedded tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's sequencing systems. The Illumina® DNA Prep with Enrichment Dx Kit is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20050020, Illumina® Prep Dx Tagmentation Reagents 1; 20050021, Illumina® DNA Prep Dx Tagmentation Reagents 2; 20050022, Illumina® Prep Dx Tagmentation Reagents 3; 20050023, Illumina® DNA Prep Dx Enrichment Reagents 1; 20050024, Illumina® DNA Prep Dx Enrichment Reagents 2; and 20050039, Illumina® Unique Dual Index Dx Set B (96 Indexes).

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

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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.