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Trusight Cystic Fibrosis Library Prep Kit — recall 64268

Health Canada — Medical Devices · Canada · 2022-06-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64268
Date of alert
2022-06-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/trusight-cystic-fibrosis-libra

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