Z-0836-2025Class II

Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of...

Name: Z-0836-2025 Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of...
Creator: Biocartis Nv
Published: 2024-12-10
License: https://open.fda.gov/license/

Biocartis NV / initiated 2024-12-10 / Open, Classified / root cause: manufacturing process

FDA source

Biocartis Nv began a recall of Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla... on 2024-12-10. FDA classified it as Class II and gives the reason as "False-positive MSI-H results generated by the Idylla MSI Test". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0836-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-10
Posted: 2025-01-10
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.
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: False-positive MSI-H results generated by the Idylla MSI Test.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 8 units
Distribution: US: AL, NJ, TX, OH, CA
Product codes and lots: UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0836-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)