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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
Noise, Audible 11 11
Display or Visual Feedback Problem 11 11
Loose or Intermittent Connection 10 10
Output Problem 9 9
Temperature Problem 9 9
Low Readings 9 9
Material Twisted/Bent 8 8
Non Reproducible Results 7 7
Use of Device Problem 7 7
Failure to Pump 6 6
Decreased Sensitivity 6 6
Suction Failure 6 6
Low Test Results 6 6
Calibration Problem 5 5
Break 5 5
Imprecision 5 5
Priming Problem 5 5
Electrical Power Problem 5 5
Intermittent Continuity 5 5
No Flow 5 5
Suction Problem 5 5
Device Ingredient or Reagent Problem 4 4
Communication or Transmission Problem 4 4
Image Display Error/Artifact 4 4
Air/Gas in Device 4 4
Complete Blockage 4 4
Patient Data Problem 3 3
Electrical Shorting 3 3
Material Deformation 3 3
Pressure Problem 3 3
Detachment of Device or Device Component 3 3
Display Difficult to Read 3 3
Data Problem 3 3
Incorrect Measurement 3 3
Connection Problem 3 3
Intermittent Communication Failure 2 2
Failure to Calibrate 2 2
Failure to Deliver 2 2
Degraded 2 2
Deformation Due to Compressive Stress 2 2
Device Sensing Problem 2 2
Defective Component 2 2
Disconnection 2 2
Volume Accuracy Problem 2 2
Partial Blockage 2 2
Computer Operating System Problem 2 2
Loss of Power 2 2
Failure to Power Up 1 1
Application Network Problem 1 1
Unintended Movement 1 1
Failure to Clean Adequately 1 1
Optical Problem 1 1
Complete Loss of Power 1 1
Low Sensing Threshold 1 1
Stretched 1 1
No Device Output 1 1
Improper or Incorrect Procedure or Method 1 1
Vibration 1 1
Power Problem 1 1
Contamination 1 1
No Visual Prompts/Feedback 1 1
Failure to Sense 1 1
False Positive Result 1 1
Fracture 1 1
Failure to Eject 1 1
Appropriate Term/Code Not Available 1 1
Component Missing 1 1
Difficult to Flush 1 1
Inadequate Lubrication 1 1
No Display/Image 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Reset 1 1
Contamination /Decontamination Problem 1 1
Circuit Failure 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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