FDA Medical Device Recalls (openFDA)
Biocartis Nv: Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
- Recall number
- Z-0836-2025
- Recalling firm
- Biocartis Nv
- Product
- Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
- Status
- Open, Classified
- Initiated
- 2024-12-10
- Posted
- 2025-01-10
- Terminated
- not on file
- Reason
- False-positive MSI-H results generated by the Idylla MSI Test.
- Root cause
- Environmental control
- Action
- 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.
- Quantity
- 8 units
- Distribution
- US: AL, NJ, TX, OH, CA
- Lot, serial or model codes
- UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OOI
- Firm FEI
- 3009972873
- Firm city
- Mechelen
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28