Lund, SE · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JOY | Device, Automated Cell-Locating | Class II | Hematology | 1 | 2020-10-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-10-08 | Class II | Ongoing | Z-0542-2026 | REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest… | — | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. |