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Idylla Instrument — recall 76770

Health Canada — Medical Devices · Canada · 2024-12-30 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 76770
Date of alert: 2024-12-30
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Chemistry
Product type: Medical devices

Reported risk: 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

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/idylla-instrument

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Idylla Instrument — recall 76770

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