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HistoCore SPECTRA CV
Leica Biosystems Nussloch GmbH · Model 000000014051454200 · UDI-DI 04049188203953
10
510(k) clearances
1,447
Adverse events (1 deaths)
30
Recalls
83
Facilities
Description
The HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply mounting media between the slide and coverglass. Then a coverglass is applied in order to preserve conserve the specimen and to create a uniform visual surface for microscopic research on histological and cytological tissue samples for medical diagnostics (e.g. cancer diagnostics). This instrument may be operated only in conjunction with the coverglasses and mounting media approved by Leica.
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 could result in smoke |
| 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 motion. This could re |
| 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 melting of the elect |
| 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 melting of the elect |
| 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 addition to the syringe t |
| 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 in anatomic patholo |
| 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 phosphorus compound. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.