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Local Run Manager CF Clinical Sequencing Analysis Module
ILLUMINA, INC. · Model 20046734 · UDI-DI 00816270020262
PFS
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
1
Facilities
Description
The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The assay detects mutations in the protein coding regions and intron/exon boundaries of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, including two large deletions and two-deep intronic mutations. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-11-13 | Illumina Inc | It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot repor |
| 2014-11-06 | Illumina Inc | Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrumen |
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