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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device equipment, laboratory, general purpose, labeled or promoted for a specific medical use
Product CodeLXG
Regulation Number 862.2050
Device Class 1

MDR Year MDR Reports MDR Events
2018 25 25
2019 27 27
2020 14 14
2021 11 11
2022 13 13
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 9 9
Break 8 8
Overheating of Device 6 6
Use of Device Problem 5 5
Unintended Movement 5 5
Appropriate Term/Code Not Available 5 5
Patient Data Problem 5 5
Non Reproducible Results 4 4
Leak/Splash 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Thermal Decomposition of Device 4 4
Electrical /Electronic Property Problem 3 3
Device Displays Incorrect Message 3 3
Device Operates Differently Than Expected 3 3
Communication or Transmission Problem 2 2
Defective Device 2 2
Labelling, Instructions for Use or Training Problem 2 2
Detachment Of Device Component 2 2
Self-Activation or Keying 2 2
Problem with Software Installation 2 2
Protective Measures Problem 1 1
Temperature Problem 1 1
Device Handling Problem 1 1
Missing Test Results 1 1
Physical Resistance/Sticking 1 1
Device Remains Activated 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
Corroded 1 1
Crack 1 1
Device Reprocessing Problem 1 1
Defective Alarm 1 1
Fluid/Blood Leak 1 1
Improper or Incorrect Procedure or Method 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Sparking 1 1
Chemical Problem 1 1
Difficult to Open or Close 1 1
Failure to Auto Stop 1 1
Device Contamination with Chemical or Other Material 1 1
Installation-Related Problem 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 37 37
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 16 16
No Patient Involvement 8 8
No Information 3 3
Insufficient Information 2 2
Test Result 1 1
Burn(s) 1 1
Death 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomedical Polymers, Inc. III Nov-05-2019
2 Dynex Technologies, Inc. II Jun-02-2022
3 Siemens Healthcare Diagnostics, Inc. II Oct-23-2018
4 Sysmex America, Inc. II Apr-14-2020
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