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Trusight cystic fibrosis library prep kit
Official notice
13 Jun 2022
Last checked
13 Jun 2022
An official Health Canada notice concerns Trusight cystic fibrosis library prep kit. 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 Published 2022-06-13.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64268
Official notice
2022-06-13
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Ilumina, Trusight Cystic Fibrosis Library Prep Kit.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
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Documents, notices & source
See the official notice and source documents for full details.
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