Class II — Biocartis Nv
| Recalling firm | Biocartis NV |
|---|---|
| Registered facility | BIOCARTIS NV (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | False-positive MSI-H results generated by the Idylla MSI Test. |
| 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. |
| Quantity | 8 units |
| Distribution | US: AL, NJ, TX, OH, CA |
| Initiated | 2024-12-10 |
| Classified | 2025-01-10 |
| Recall number | Z-0836-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biocartis Nv (Z-0836-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96022/
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