Home › Device types › JOY
Device, Automated Cell-Locating
FDA product code JOY · Class 2 · Hematology
213
Registered devices
18
Adverse events
4
Recalls
35
510(k) clearances
Devices with this code
Leica Biosystems CytoVision GSL120 scanning system for Karyotyping — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision Capture Station Upgrade with Jai CVM2 — Leica Biosystems Richmond, Inc.X100HT System — SCOPIO LABS LTDLeica Biosystems CytoVision Microscope Leica DM6000B for GSL — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision Remote User (Karyotype & FISH) — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision Microscope, Leica DM5000B — Leica Biosystems Richmond, Inc.CellaVision® Advanced RBC Application DM96 — Cellavision ABLeica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro — Leica Biosystems Richmond, Inc.Leica Biosystems Leica dmrb 91007 82000 CU 32mm exciters — Leica Biosystems Richmond, Inc.Leica ADAPTOR C14 TO C7, POWER SUPPLY — Leica Biosystems Richmond, Inc.CellaVision DC-1 — Cellavision ABLeica Biosystems CytoVision Capture station upgrade use existing DFC — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision X-Cite Basic Unit — Leica Biosystems Richmond, Inc.Leica Biosystems Lamp Housing 106, 12V 100W, 2 Lens, 0,55 — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision DM5500 B CytoVision Basic Configuration — Leica Biosystems Richmond, Inc.Leica Biosystems SURGE SUPPRESSOR ISOBAR6ULTRAHG-120V — Leica Biosystems Richmond, Inc.GenASIs™ System — APPLIED SPECTRAL IMAGING LTD.Leica Biosystems CytoVision OBJ HC PL APO 10X — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision FISH Review Station — Leica Biosystems Richmond, Inc.CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH — Leica Biosystems Richmond, Inc.CellaVision® Remote Review Software, Enterprise Edition, version independent — Cellavision ABLeica Biosystems CytoVision 7.5 Warranty upgrade DVD — Leica Biosystems Richmond, Inc.Smart-UPS SMC1500i 1500VA 230V — Leica Biosystems Richmond, Inc.Leica Biosystems CytoVision GSL 10 & 120 Fluorescence Upgrade — 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.