Idylla INSTRUMENT — Class II medical device recall Z-0836-2025
Ongoing recall by Biocartis Nv, reported 2025-01-22, distributed in AL, CA, NJ, OH, TX. False-positive MSI-H results generated by the Idylla MSI Test.
| Recall number | Z-0836-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocartis Nv, Mechelen, Belgium |
| Recall initiated | 2024-12-10 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | AL, CA, NJ, OH, TX |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 05415219000119 |
| Serial numbers | 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, 00003445 |
| Model numbers | P0010 |
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.
Reason for recall
False-positive MSI-H results generated by the Idylla MSI Test.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0836-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.