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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
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
2019 2 2
2020 134 134
2021 324 324
2022 874 874
2023 223 223
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 451 451
Program or Algorithm Execution Problem 316 316
Incorrect, Inadequate or Imprecise Result or Readings 282 282
Device Dislodged or Dislocated 194 194
Fluid/Blood Leak 139 139
Mechanical Problem 53 53
False Negative Result 45 45
Unable to Obtain Readings 30 30
Structural Problem 22 22
Smoking 19 19
No Apparent Adverse Event 15 15
Sparking 7 7
Temperature Problem 6 6
Human-Device Interface Problem 5 5
Detachment of Device or Device Component 5 5
Patient Data Problem 4 4
Unintended Electrical Shock 3 3
Leak/Splash 3 3
Overheating of Device 2 2
Fire 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 2 2
Non Reproducible Results 2 2
Difficult to Open or Close 2 2
Device Fell 2 2
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Insufficient Information 1 1
Data Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Mechanical Jam 1 1
Patient-Device Incompatibility 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Fumes or Vapors 1 1
Crack 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Melted 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Failure to Power Up 1 1
Use of Device Problem 1 1
Volume Accuracy Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1461 1461
No Consequences Or Impact To Patient 108 108
No Known Impact Or Consequence To Patient 19 19
No Patient Involvement 17 17
Insufficient Information 9 9
Abrasion 4 4
Test Result 2 2
Electric Shock 2 2
No Information 1 1
Tingling 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Numbness 1 1
Head Injury 1 1
Pain 1 1
Discomfort 1 1
Limb Fracture 1 1
Swelling 1 1
Pallor 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Apr-06-2023
2 Abbott Molecular, Inc. II Jan-20-2023
3 Abbott Molecular, Inc. II Nov-18-2022
4 Abbott Molecular, Inc. II Mar-02-2022
5 DiaSorin Molecular LLC II Jul-18-2023
6 DiaSorin Molecular LLC II Jan-05-2022
7 Hologic, Inc. II Jan-23-2024
8 Luminex Corporation II May-13-2022
9 Luminex Corporation II Feb-02-2022
10 Luminex Corporation II Jan-14-2022
11 Luminex Corporation II Aug-19-2019
12 Luminex Corporation II Aug-15-2019
13 Meridian Bioscience Inc II Jul-28-2022
14 Meridian Bioscience Inc II Mar-30-2022
15 Qiagen Sciences LLC II Mar-12-2020
16 Roche Molecular Systems, Inc. II Mar-28-2022
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