| Device Type ID | 586 |
| Device Name | Fluorometer, For Clinical Use |
| Regulation Description | Fluorometer For Clinical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2560 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KHO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 586 |
| Device | Fluorometer, For Clinical Use |
| Product Code | KHO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Fluorometer For Clinical Use. |
| CFR Regulation Number | 862.2560 [🔎] |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 874 |
Device Operates Differently Than Expected | 631 |
Device Operational Issue | 547 |
Device Issue | 374 |
Mechanical Problem | 319 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 189 |
Imprecision | 71 |
Incorrect Or Inadequate Test Results | 64 |
Output Problem | 51 |
Maintenance Does Not Comply To Manufacturers Recommendations | 48 |
False Reading From Device Non-Compliance | 46 |
Device Component Or Accessory | 19 |
Failure To Align | 19 |
Leak / Splash | 17 |
Electrical /Electronic Property Problem | 17 |
Low Readings | 15 |
Low Test Results | 15 |
Calibration Problem | 15 |
High Test Results | 13 |
High Readings | 13 |
Use Of Device Problem | 13 |
Bent | 12 |
Temperature Problem | 10 |
Fluid Leak | 10 |
Computer Software Problem | 9 |
Probe | 8 |
Noise, Audible | 8 |
Device Sensing Problem | 8 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Device Maintenance Issue | 7 |
Human Factors Issue | 7 |
Partial Blockage | 6 |
No Display / Image | 6 |
Obstruction Of Flow | 6 |
Physical Property Issue | 5 |
Computer Operating System Problem | 5 |
Complete Blockage | 5 |
Computer Hardware | 4 |
Failure To Calibrate | 4 |
Connection Problem | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Contamination During Use | 3 |
Break | 3 |
Pump | 3 |
Inadequate Or Insufficient Training | 3 |
Positioning Failure | 2 |
Mechanical Jam | 2 |
Fitting Problem | 2 |
Inaccurate Delivery | 2 |
Naturally Worn | 2 |
Malposition Of Device | 2 |
Unable To Obtain Readings | 2 |
Belt | 2 |
Power Problem | 2 |
Mechanism | 2 |
Device Ingredient Or Reagent Problem | 2 |
Communication Or Transmission Problem | 2 |
Wire | 2 |
Syringe | 2 |
Appropriate Term/Code Not Available | 2 |
Suction Problem | 2 |
Power Supply | 2 |
Screw | 1 |
Printer | 1 |
Component Missing | 1 |
Inadequate Instructions For Healthcare Professional | 1 |
Failure To Pump | 1 |
Failure To Recalibrate | 1 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 |
No Flow | 1 |
Non Reproducible Results | 1 |
Cable | 1 |
Fire | 1 |
Fracture | 1 |
Infusion Or Flow Problem | 1 |
Operating System Becomes Nonfunctional | 1 |
Nozzle | 1 |
Image Resolution Poor | 1 |
Defective Component | 1 |
Improper Device Output | 1 |
Issue With Displayed Error Message | 1 |
Failure To Advance | 1 |
Defective Alarm | 1 |
Loose Or Intermittent Connection | 1 |
Short Fill | 1 |
Split | 1 |
Blocked Connection | 1 |
Device Slipped | 1 |
Crack | 1 |
Overheating Of Device | 1 |
Incomplete Or Inadequate Priming | 1 |
Detachment Of Device Component | 1 |
Image Display Error / Artifact | 1 |
Sticking | 1 |
Chemical Spillage | 1 |
Device Contamination With Biological Material | 1 |
Material Deformation | 1 |
Operating System Version Or Upgrade Problem | 1 |
Device Handling Problem | 1 |
False Device Output | 1 |
| Total Device Problems | 3590 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | PerkinElmer Health Sciences, Inc. | III | Oct-11-2018 |
| 2 | PerkinElmer Life And Analytical Sciences, Wallac, OY | II | Jan-27-2017 |
| 3 | Tecan US, Inc. | II | Jul-02-2015 |
| 4 | Tecan US, Inc. | III | Jan-15-2015 |
| 5 | Tosoh Bioscience Inc | II | Dec-14-2018 |
| 6 | Tosoh Bioscience Inc | II | Dec-13-2018 |
| 7 | Tosoh Bioscience Inc | II | Dec-13-2018 |
| 8 | Tosoh Bioscience Inc | II | Dec-06-2018 |
| 9 | Tosoh Bioscience Inc | II | Nov-28-2018 |
| 10 | Tosoh Bioscience Inc | II | Nov-19-2018 |
| 11 | Tosoh Bioscience Inc | II | Nov-16-2018 |
| 12 | Tosoh Bioscience Inc | II | Nov-14-2018 |
| 13 | Tosoh Bioscience Inc | II | Jan-31-2018 |