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Health Canada Medical devices

Trusight Cystic Fibrosis Library Prep Kit

Issued June 13, 2022
Issue
Annotation error in analysis software - the genomic coordinate reported for one variant in the sample did not match the cDNA name; the variant corresponding to the genomic coordinate is not cystic fibrosis-causing, but the cDNA name is potentially cystic fibrosis-causing (software issue/malfunction). Affected device details: catalog #20036925, affected software: local run manager (lrm) cf clinical seq 2.0 analysis module, software version:1.0.0.56, affected report file: trusightcfclinicalsequencingassay.txt. Recall start date: May 25, 2022
Hazard description
Performance
Product
Product name
Trusight Cystic Fibrosis Library Prep Kit
Reference
ID
RA-64268