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TruSeq Custom Amplicon Kit Dx - FFPE QC

ILLUMINA, INC. · Model 20006259 · UDI-DI 00816270020064

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Description

DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.

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.