Mechelen, BE · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PZJ | Lynch Syndrome Test System | Class II | Immunology | 1 | 2023-02-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-12-10 | Class II | Ongoing | Z-0836-2025 | Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples… | — | False-positive MSI-H results generated by the Idylla MSI Test. |