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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluorometer, for clinical use
Product CodeKHO
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 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 842 896
Incorrect, Inadequate or Imprecise Result or Readings 219 233
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 14 14
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
Low Test Results 6 6
Decreased Sensitivity 6 6
Calibration Problem 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 793 793
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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