Home › Device types › KHO
Fluorometer, For Clinical Use
FDA product code KHO · Class 1 · Clinical Chemistry
57
Registered devices
4,551
Adverse events
32
Recalls
38
510(k) clearances
Devices with this code
VICTOR2 D — Wallac OyImmunofluorescence Reader — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NA — Guangzhou Labsim Biotech Co., LtdRAMP® 200 CM Control Module — Response Biomedical CorpAFIAS TSH-SP — Boditech Med Inc.AFIAS-6/SP Analyzer — Boditech Med Inc.Ariel Fluorescent Immunoassay System — SANWA BIOTECH LIMITEDGenetic Screening Processor — Wallac OyTriage — QUIDEL CARDIOVASCULAR INC.AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST — TOSOH CORPORATIONAUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 — TOSOH CORPORATIONSofia — QUIDEL CORPORATIONSofia — QUIDEL CORPORATIONSEEKER™ — Baebies, Inc.AutoDELFIA Plate processor — Wallac OyAutoDELFIA Automatic Immunoassay System — Wallac OyHealgen — HEALGEN LIFE SCIENCE, LLCVICTOR EnLite — Wallac OySofia — QUIDEL CORPORATIONFREND System — NanoEnTek, Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 LA — TOSOH CORPORATIONabioSCOPE — Abionic SAAutoDELFIA Sample processor — Wallac Oy
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 pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor m |
| 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 |
| 2018-09-28 | 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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