Official recall record
Idylla Instrument
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-12-30
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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