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Healgen
HEALGEN LIFE SCIENCE, LLC · Model OG-H180 · UDI-DI 00850076346010
KHO
Prescription
1
510(k) clearances
4,519
Adverse events
32
Recalls
51
Facilities
Description
The Healgen Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. It is designed to perform in vitro diagnostic tests on clinical specimens including drug urine test.
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.