Home › Device types › KPA
Slide Stainer, Automated
FDA product code KPA · Class 1 · Pathology
284
Registered devices
1,451
Adverse events
30
Recalls
21
510(k) clearances
Devices with this code
Aerospray® Gram Slide Stainer/Cytocentrifuge — ELITECHGROUP INC.Thermo Fisher — SHANDON DIAGNOSTICS LIMITEDThermo Fisher — SHANDON DIAGNOSTICS LIMITEDOptional Plexiglas Hood — Leica Biosystems Nussloch GmbHBOND-PRIME automated stainer — LEICA BIOSYSTEMS MELBOURNE PTY LTDTintoStainer Plus Automated System — BIO SB, INC.Lumatas Automated Slide Stainer — Lumatas Biosystems, Inc.Blocking plug — Leica Biosystems Nussloch GmbHPREVI® COLOR 30 SLIDES CAROUSEL — BIOMERIEUX SARack holder, assy. — Leica Biosystems Nussloch GmbHHistoCore SPECTRA CV — Leica Biosystems Nussloch GmbHHeatable reagent st. kit — Leica Biosystems Nussloch GmbHintelliPATH MAX — BIOCARE MEDICAL LLCEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDBOND — LEICA BIOSYSTEMS MELBOURNE PTY LTDMD Stainer — Pathcom Systems CorporationAerospray TB Slide Stainer/Cytocentrifuge — ELITECHGROUP INC.Thermo Fisher — SHANDON DIAGNOSTICS LIMITEDHigh Lighter — Pathcom Systems CorporationEpredia — SHANDON DIAGNOSTICS LIMITEDLeica ST5020 Config. 3 — Leica Biosystems Nussloch GmbHEpredia — SHANDON DIAGNOSTICS LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-02 | Agilent Technologies | There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury. |
| 2022-06-01 | Ventana Medical Systems Inc | There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire |
| 2022-01-20 | Ventana Medical Systems Inc | Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that co |
| 2021-04-16 | Hardy Diagnostics | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. |
| 2021-02-25 | Biocare Medical, LLC | Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of m |
| 2020-08-31 | Roche Diagnostics Operations, Inc. | Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and |
| 2020-08-31 | Roche Diagnostics Operations, Inc. | Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and |
| 2019-11-05 | Dako Denmark A/S | The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addit |
| 2019-10-04 | Ventana Medical Systems Inc | The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples |
| 2018-09-17 | Leica Microsystems, Inc. | The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphor |
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