Health product recall

Trusight Cystic Fibrosis Library Prep Kit

Brand(s)
Last updated

Summary

Product
Trusight Cystic Fibrosis Library Prep Kit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Trusight Cystic Fibrosis Library Prep Kit

00816270020149

20036925

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

Additional information

Details
Original published date: 2022-06-16
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Companies

Illumina, Inc.

5200 Illumina Way, San Diego, California, United States, 92122

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64268