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TPLC
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show TPLC since
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2024
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Device
fluorometer, for clinical use
Product Code
KHO
Regulation Number
862.2560
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
440
496
2020
257
257
2021
213
213
2022
224
224
2023
260
260
2024
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
839
893
Incorrect, Inadequate or Imprecise Result or Readings
217
231
Electrical /Electronic Property Problem
47
47
Failure to Align
44
44
Obstruction of Flow
33
33
High Readings
27
27
High Test Results
25
25
Infusion or Flow Problem
14
14
Fluid/Blood Leak
13
13
Computer Software Problem
12
14
Leak/Splash
12
12
Mechanical Jam
12
12
Display or Visual Feedback Problem
11
11
Noise, Audible
11
11
Loose or Intermittent Connection
10
10
Output Problem
9
9
Low Readings
9
9
Temperature Problem
9
9
Material Twisted/Bent
8
8
Use of Device Problem
7
7
Non Reproducible Results
7
7
Suction Failure
6
6
Failure to Pump
6
6
Decreased Sensitivity
6
6
Calibration Problem
5
5
Low Test Results
5
5
Imprecision
5
5
No Flow
5
5
Electrical Power Problem
5
5
Suction Problem
5
5
Intermittent Continuity
5
5
Break
5
5
Priming Problem
5
5
Air/Gas in Device
4
4
Complete Blockage
4
4
Image Display Error/Artifact
4
4
Device Ingredient or Reagent Problem
4
4
Communication or Transmission Problem
4
4
Connection Problem
3
3
Detachment of Device or Device Component
3
3
Electrical Shorting
3
3
Material Deformation
3
3
Display Difficult to Read
3
3
Incorrect Measurement
3
3
Pressure Problem
3
3
Data Problem
3
3
Patient Data Problem
3
3
Intermittent Communication Failure
2
2
Loss of Power
2
2
Defective Component
2
2
Volume Accuracy Problem
2
2
Partial Blockage
2
2
Degraded
2
2
Disconnection
2
2
Device Sensing Problem
2
2
Deformation Due to Compressive Stress
2
2
Computer Operating System Problem
2
2
Failure to Deliver
2
2
Failure to Calibrate
2
2
Contamination /Decontamination Problem
1
1
Low Sensing Threshold
1
1
Application Network Problem
1
1
Power Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Optical Problem
1
1
Contamination
1
1
Circuit Failure
1
1
No Display/Image
1
1
False Positive Result
1
1
Difficult to Flush
1
1
Fracture
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Vibration
1
1
Failure to Sense
1
1
Stretched
1
1
Failure to Power Up
1
1
Failure to Reset
1
1
No Device Output
1
1
Failure to Clean Adequately
1
1
Inadequate Lubrication
1
1
Unintended Movement
1
1
Appropriate Term/Code Not Available
1
1
Failure to Eject
1
1
Complete Loss of Power
1
1
No Visual Prompts/Feedback
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
786
786
No Known Impact Or Consequence To Patient
624
680
Insufficient Information
10
10
No Consequences Or Impact To Patient
3
3
Electric Shock
1
1
Missing Value Reason
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ortho-Clinical Diagnostics
II
May-06-2019
2
Tosoh Bioscience Inc
II
Jun-23-2020
3
Tosoh Bioscience Inc
II
Feb-11-2020
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