Home › Device types › JOY
Device, Automated Cell-Locating
FDA product code JOY · Class 2 · Hematology
212
Registered devices
18
Adverse events
4
Recalls
35
510(k) clearances
Devices with this code
Leica Biosystems CytoVision Station Upgrade existing Dual Jai CVM4 — Leica Biosystems Richmond, Inc.Dell Precision 5820 — Leica Biosystems Richmond, Inc.Leica Biosystems GSL120-Base Assembly BX — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision MB8 scanning system for FISH — Leica Biosystems Richmond, Inc.Leica Biosystems GSL10 BF Scanning Sytem Upgrade — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision MB8 scanning system for Karyotyping&FISH — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision Flexible Karyotyper License Activation — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision FISH review software (inc. dongle) — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision OBJ HC PL FL 63X — Leica Biosystems Richmond, Inc.Automated Digital Morphology Analyzer DI-60 — Cellavision ABLeica Biosystems CytoVision DM5500B for Brightfield & FL — Leica Biosystems Richmond, Inc.Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM — Leica Biosystems Richmond, Inc.CellaVision DC-1 PPA — Cellavision ABLeica Biosystems CytoVision DM 6000B KF for MB8 upgrade — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision CytoLink Data Service Module — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision DM5000 B ERGO Head Version — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision Karyotyping Software Upgrade — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision OBJ HC PL FL 1.25X — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision Karyotyping & FISH Review software — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision KVM/Monitor — Leica Biosystems Richmond, Inc.Leica Biosystems HIGH TRANSM. GREEN FOR LEICA DM — Leica Biosystems Richmond, Inc.X100HT Processing Unit — SCOPIO LABS LTDLeica Biosystems CytoVision DM2500 for Brightfield — Leica Biosystems Richmond, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-08 | Cellavision AB | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. |
| 2018-05-07 | Roche Diagnostics Hematology | Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected: RB |
| 2017-12-04 | Cellavision AB | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers pro |
| 2016-05-02 | Leica Biosystems Richmond Inc. | Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be |
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