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MiSeqDx Universal Kit 1.0

ILLUMINA, INC. · Model 15038741 · UDI-DI 00816270020040

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. MiSeqDx Universal Kit 1.0 (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15039490 MiSeqDx Universal Kit 1.0 1/5 15039485 MiSeqDx Universal Kit 1.0 1A 15039488 MiSeqDx Universal Kit 1.0 1B 15039492 MiSeqDx Universal Kit 1.0 2/5 15039498 MiSeqDx Universal Kit 1.0 3/5 15039494 MiSeqDx Universal Kit 1.0 3A 15039496 MiSeqDx Universal Kit 1.0 3B 15039500 MiSeqDx Universal Kit 1.0 4/5 15039503 MiSeqDx Universal Kit 1.0 5/5

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.