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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
2014 7 7
2015 15 15
2016 12 12
2017 14 14
2018 25 25
2019 27 27
2020 14 14
2021 11 11
2022 13 13
2023 11 11
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 16 16
Break 13 13
Device Operates Differently Than Expected 12 12
Unintended Movement 7 7
Overheating of Device 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Device Emits Odor 5 5
Use of Device Problem 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Patient Data Problem 5 5
Non Reproducible Results 5 5
Device Markings/Labelling Problem 5 5
Device Displays Incorrect Message 4 4
Thermal Decomposition of Device 4 4
Leak/Splash 4 4
Fluid/Blood Leak 4 4
Hole In Material 3 3
Electrical /Electronic Property Problem 3 3
False Negative Result 3 3
Incorrect Measurement 3 3
Improper or Incorrect Procedure or Method 3 3
Device Operational Issue 3 3
Smoking 3 3
Communication or Transmission Problem 3 3
Failure to Auto Stop 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Problem with Software Installation 2 2
Low Test Results 2 2
Defective Device 2 2
Device Remains Activated 2 2
Self-Activation or Keying 2 2
Labelling, Instructions for Use or Training Problem 2 2
Detachment Of Device Component 2 2
Component Falling 2 2
Corroded 1 1
Crack 1 1
Device Reprocessing Problem 1 1
Defective Alarm 1 1
Failure to Back-Up 1 1
Fire 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Unintended System Motion 1 1
Material Puncture/Hole 1 1
Sparking 1 1
Chemical Problem 1 1
Chemical Spillage 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Output Problem 1 1
Power Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Installation-Related Problem 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Detachment of Device or Device Component 1 1
Device Inoperable 1 1
Difficult to Open or Close 1 1
Electrical Shorting 1 1
Inaccurate Information 1 1
Device Handling Problem 1 1
Missing Test Results 1 1
Physical Resistance/Sticking 1 1
Missing Value Reason 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 63 63
No Clinical Signs, Symptoms or Conditions 34 34
No Consequences Or Impact To Patient 27 27
No Patient Involvement 11 11
No Information 3 3
No Code Available 3 3
Insufficient Information 2 2
Burn(s) 2 2
Laceration(s) 2 2
Pain 2 2
Urinary Retention 1 1
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Loss of consciousness 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-19-2011
2 Biomedical Polymers, Inc. III Nov-05-2019
3 Biomerieux Inc II Oct-09-2012
4 Dynex Technologies, Inc. II Jun-02-2022
5 Helena Laboratories, Corp. II Jun-16-2023
6 Roche Diagnostics Corp. II May-18-2009
7 Roche Diagnostics Operations, Inc. II Aug-29-2011
8 Siemens Healthcare Diagnostics Inc. II Jun-29-2016
9 Siemens Healthcare Diagnostics, Inc. II Oct-23-2018
10 Siemens Medical Solutions Diagnostics III Jun-19-2014
11 Sysmex America, Inc. II Apr-14-2020
12 Tecan US, Inc. II Aug-25-2016
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