Genetic Screening Processor
Wallac Oy · Model 2021-0010 · UDI-DI 06438147311040
1
510(k) clearances
4,551
Adverse events
32
Recalls
52
Facilities
Description
The GSP® instrument is a fully automated, high throughput batch analyzer for time-resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-22 | Tosoh Bioscience Inc | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results. |
| 2020-01-10 | Tosoh Bioscience Inc | A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the |
| 2019-02-20 | Ortho-Clinical Diagnostics | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems |
| 2019-02-20 | Ortho-Clinical Diagnostics | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems |
| 2018-10-05 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the ana |
| 2018-10-05 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between t |
| 2018-09-28 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If |
| 2018-09-28 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If |
| 2018-09-28 | Tosoh Bioscience Inc | There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during th |
| 2018-09-28 | Tosoh Bioscience Inc | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released softw |
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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.