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Health Canada Medical devices

Idylla Instrument

Issued December 30, 2024
Issue
Biocartis received a complaint on several Idylla MSI test false positive results generated on a single instrument. As part of the investigation, Biocartis conducted a review of the Idylla MSI test performance in the field. A review of all connected runs from 2019 to date identified suspected false positive Idylla MSI test runs obtained by customers in Germany, Italy, Poland, Estonia, Cyprus, and Thailand. Recall start date: December 9, 2024
Hazard description
Performance
Product
Product name
Idylla Instrument
Reference
ID
RA-76770