Home › Device types › KHO
Fluorometer, For Clinical Use
FDA product code KHO · Class 1 · Clinical Chemistry
56
Registered devices
4,519
Adverse events
32
Recalls
38
510(k) clearances
Devices with this code
ALiA FIA Analyser — SANWA BIOTECH LIMITEDVICTOR2 D — Wallac OyBoditech TSH Control — Boditech Med Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.INFINITE 200 PRO — Tecan Austria GmbHAFIAS TSH-VB — Boditech Med Inc.abioSCOPE — Abionic SABioeasy Immunofluorescence Analyzer — Shenzhen Superbio Technology Co., Ltd.NA — Guangzhou Labsim Biotech Co., LtdAutoDELFIA Sample processor — Wallac OyHealgen — HEALGEN LIFE SCIENCE, LLCASFA SCANNER — MBD CO., Ltd.AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 — TOSOH CORPORATIONFREND System — NanoEnTek, Inc.ASFA® SCANNER — MBD CO., Ltd.AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 — TOSOH CORPORATIONMacro & Micro-Test Fluorescence Immunoassay Analyzer — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.SEEKER™ — Baebies, Inc.AutoDELFIA Automatic Immunoassay System — Wallac OyTriage — QUIDEL CARDIOVASCULAR INC.Ariel Fluorescent Immunoassay System — SANWA BIOTECH LIMITED19tray Sorter — TOSOH CORPORATIONAFIAS TSH-SP — Boditech Med Inc.AFIAS-6/SP Analyzer — Boditech Med Inc.
Recent 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 fi |
| 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 axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the t |
| 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 m |
| 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 |
| 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. Toso |
| 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 wit |
| 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 wit |
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