Trusight Cystic Fibrosis Library Prep Kit
Brand(s)
Last updated
Summary
Product
Trusight Cystic Fibrosis Library Prep Kit
Issue
Medical devices - Performance
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
Get notified
Receive emails about new and updated recall and safety alerts.