Biocartis Nv recalls Idylla INSTRUMENT

False-positive MSI-H results generated by the Idylla MSI Test.

Biocartis issued an URGENT - Medical Device Correction notice to its consignees on 12/10/2024 via email. The notice provided the description of the problem, its impact, and requested the following actions be taken: 1. Until your Instrument is serviced, please move forward with the option that applies to your situation: o In case you have another Idylla Instrument available that is not affected, use that Instrument to run the Idylla MSI Test and discontinue running the Idylla MSI Test on the listed Instrument(s). o No new Idylla MSI testing should be performed using the affected Idylla Instruments. o For results already obtained using an affected Idylla Instrument, the following apply: o MSS results are VALID and may be reported. o MSI-H (Microsatellite Instability High) results with six or seven positive identified biomarkers (as depicted in the result report) are VALID and may be reported. o MSI-H results other than those with six or seven positive identified biomarkers are INVALID and should NOT be reported or used to manage patient health. Patient samples with these results should be re-tested on an Idylla Instrument that is NOT affected. 2. If you are not the Idylla user, please forward this notice to the Idylla end user or Idylla supervisor and provide Biocartis with the correct contact details for our record keeping. 3. Completion of the Acknowledgement of Receipt (Appendix 2) is required for compliance. Please complete and sign the attached Acknowledgement of Receipt form by December 17, 2024, and send it to vigilance@biocartis.com.

• FDA enforcement recordOfficial FDA database entry for Z-0836-2025
• FDA device classification · OOIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Biocartis NvSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.