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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device real time nucleic acid amplification system
Regulation Description Instrumentation for clinical multiplex test systems.
Definition The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.
Product CodeOOI
Regulation Number 862.2570
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIDIAN BIOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 134 134
2021 324 324
2022 874 874
2023 223 223
2024 329 330
2025 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 712 712
Program or Algorithm Execution Problem 316 316
Incorrect, Inadequate or Imprecise Result or Readings 298 298
Device Dislodged or Dislocated 194 194
Fluid/Blood Leak 176 176
False Negative Result 57 57
Mechanical Problem 53 53
Unable to Obtain Readings 51 52
Structural Problem 34 34
Smoking 21 21
No Apparent Adverse Event 15 15
Sparking 7 7
Human-Device Interface Problem 7 7
Temperature Problem 6 6
Detachment of Device or Device Component 5 5
Patient Data Problem 4 4
Leak/Splash 3 3
Fire 3 3
Failure to Obtain Sample 3 3
Unintended Electrical Shock 3 3
Non Reproducible Results 2 2
Device Fell 2 2
Overheating of Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Difficult to Open or Close 2 2
Output Problem 2 2
Failure to Power Up 1 1
Device Markings/Labelling Problem 1 1
Low Readings 1 1
Insufficient Information 1 1
Mechanical Jam 1 1
Electrical /Electronic Property Problem 1 1
Data Problem 1 1
No Display/Image 1 1
Device Damaged by Another Device 1 1
Thermal Decomposition of Device 1 1
Device Ingredient or Reagent Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Fumes or Vapors 1 1
Volume Accuracy Problem 1 1
Defective Component 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Melted 1 1
Improper or Incorrect Procedure or Method 1 1
Ejection Problem 1 1
Unintended Movement 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1827 1828
No Consequences Or Impact To Patient 108 108
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 17 17
Insufficient Information 9 9
Abrasion 5 5
Test Result 2 2
Electric Shock 2 2
Head Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Limb Fracture 1 1
No Information 1 1
Skin Tears 1 1
Pallor 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Apr-19-2024
2 Abbott Molecular, Inc. III Feb-26-2024
3 Abbott Molecular, Inc. II Apr-06-2023
4 Abbott Molecular, Inc. II Jan-20-2023
5 Abbott Molecular, Inc. II Nov-18-2022
6 Abbott Molecular, Inc. II Mar-02-2022
7 Biocartis Nv II Jan-10-2025
8 DiaSorin Molecular LLC II Jul-18-2023
9 DiaSorin Molecular LLC II Jan-05-2022
10 Hologic, Inc. II Jan-23-2024
11 Luminex Corporation II May-13-2022
12 Luminex Corporation II Feb-02-2022
13 Luminex Corporation II Jan-14-2022
14 Meridian Bioscience Inc II Jul-28-2022
15 Meridian Bioscience Inc II Mar-30-2022
16 Qiagen Sciences LLC II Mar-12-2020
17 Roche Molecular Systems, Inc. II Mar-28-2022
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