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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
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Product CodeLXG
Regulation Number 862.2050
Device Class 1

MDR Year MDR Reports MDR Events
2016 12 12
2017 14 14
2018 25 25
2019 27 27
2020 14 14
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12 12
Device Operates Differently Than Expected 8 8
Overheating of Device 6 6
Break 6 6
Insufficient Information 5 5
Patient Data Problem 5 5
Appropriate Term/Code Not Available 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Use of Device Problem 4 4
Thermal Decomposition of Device 4 4
Unintended Movement 4 4
Non Reproducible Results 4 4
Device Displays Incorrect Message 3 3
False Negative Result 3 3
Hole In Material 3 3
Labelling, Instructions for Use or Training Problem 2 2
Device Emits Odor 2 2
Fluid Leak 2 2
Defective Device 2 2
Failure to Auto Stop 2 2
Problem with Software Installation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment Of Device Component 2 2
Leak/Splash 2 2
Self-Activation or Keying 2 2
Improper or Incorrect Procedure or Method 1 1
Low Test Results 1 1
Unintended System Motion 1 1
Device Remains Activated 1 1
Component Falling 1 1
Corroded 1 1
Electrical /Electronic Property Problem 1 1
Defective Alarm 1 1
Physical Resistance/Sticking 1 1
Chemical Problem 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Installation-Related Problem 1 1
Output Problem 1 1
Missing Value Reason 1 1
Sparking 1 1
Material Puncture/Hole 1 1
Difficult to Open or Close 1 1
Device Reprocessing Problem 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 46 46
No Consequences Or Impact To Patient 26 26
No Patient Involvement 10 10
No Clinical Signs, Symptoms or Conditions 6 6
No Information 3 3
Pain 2 2
Insufficient Information 2 2
Loss of consciousness 1 1
Urinary Retention 1 1
Test Result 1 1
No Code Available 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomedical Polymers, Inc. III Nov-05-2019
2 Siemens Healthcare Diagnostics Inc. II Jun-29-2016
3 Siemens Healthcare Diagnostics, Inc. II Oct-23-2018
4 Sysmex America, Inc. II Apr-14-2020
5 Tecan US, Inc. II Aug-25-2016
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