Home › Device types › KPA
Slide Stainer, Automated
FDA product code KPA · Class 1 · Pathology
281
Registered devices
1,446
Adverse events
30
Recalls
21
510(k) clearances
Devices with this code
ABX SPS EVOLUTION — HORIBA ABX SASAdapter - Medite 30 — Leica Biosystems Nussloch GmbHCOMPASS STAINER — Hologic, Inc.Dako Omnis 110 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD12-slide vented carousel for Aerospray® — ELITECHGROUP INC.Stain F Empty Bottle with Level Detect, Cytology Stainer — ELITECHGROUP INC.Leica ST5020, Basic Instrument — Leica Biosystems Nussloch GmbHDako Omnis Waste Tank (NHz) — AGILENT TECHNOLOGIES SINGAPORE PTE LTDPREVI® COLOR GRAM V2 — BIOMERIEUX SAPREVI® COLOR SINGLE SAMPLE CHAMBERS SLOW (TAN) — BIOMERIEUX SAPREVI® COLOR POLY-L-LYSINE SLIDES SINGLE — BIOMERIEUX SASpecial stain insert — Leica Biosystems Nussloch GmbHintelliPATH Plus — BIOCARE MEDICAL LLCVENTANA HE 600 System — Ventana Medical Systems, Inc.BOND — LEICA BIOSYSTEMS MELBOURNE PTY LTDOncore Pro — Pathcom Systems CorporationHematek® 3000 System — Siemens Healthcare Diagnostics Products GmbHAtellica HEMA Slidemaker Stainer (SMS) — Siemens Healthcare Diagnostics Inc.BenchMark XT — Ventana Medical Systems, Inc.Dako Omnis Waste Accessories (Direct) — AGILENT TECHNOLOGIES SINGAPORE PTE LTDDecloaking Chamber™ NxGen Reconditioned — BIOCARE MEDICAL LLCAlinity — Abbott GmbHHisto-Tek® — SAKURA FINETEK U.S.A., INC.Thermo Fisher — 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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