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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device immunoassay method, troponin subunit
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeMMI
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT POINT OF CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 387 387
2021 356 356
2022 507 507
2023 756 756
2024 931 931
2025 322 322

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2528 2528
Non Reproducible Results 617 617
False Positive Result 324 324
Low Test Results 182 182
Incorrect, Inadequate or Imprecise Result or Readings 124 124
Incorrect Measurement 59 59
No Apparent Adverse Event 41 41
False Negative Result 37 37
High Readings 21 21
Output Problem 17 17
Unable to Obtain Readings 7 7
Low Readings 6 6
Material Integrity Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Mechanical Problem 4 4
Contamination of Device Ingredient or Reagent 4 4
Signal Artifact/Noise 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Use of Device Problem 3 3
Device Difficult to Maintain 2 2
Product Quality Problem 2 2
Compatibility Problem 2 2
Contamination 1 1
Erratic Results 1 1
Imprecision 1 1
Nonstandard Device 1 1
No Device Output 1 1
Unexpected Therapeutic Results 1 1
Device Damaged Prior to Use 1 1
Failure to Calibrate 1 1
Device Displays Incorrect Message 1 1
Contamination /Decontamination Problem 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2592 2592
No Known Impact Or Consequence To Patient 203 203
Chest Pain 101 101
No Consequences Or Impact To Patient 91 91
Insufficient Information 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
No Code Available 21 21
Dizziness 18 18
Myocardial Infarction 16 16
High Blood Pressure/ Hypertension 15 15
Abdominal Pain 10 10
Pain 10 10
Dyspnea 9 9
Decreased Respiratory Rate 8 8
Cardiac Enzyme Elevation 8 8
Nausea 7 7
Heart Failure/Congestive Heart Failure 6 6
Unspecified Respiratory Problem 5 5
Syncope/Fainting 5 5
No Information 5 5
Vomiting 4 4
Respiratory Distress 4 4
Pneumonia 4 4
Respiratory Insufficiency 4 4
Cough 4 4
Headache 4 4
Dehydration 4 4
Fall 4 4
Ischemic Heart Disease 3 3
Adult Respiratory Distress Syndrome 3 3
Respiratory Failure 3 3
Myocarditis 3 3
Patient Problem/Medical Problem 3 3
Pyrosis/Heartburn 3 3
Diarrhea 3 3
Fever 3 3
Anxiety 3 3
Fatigue 3 3
Atrial Fibrillation 3 3
Asthma 3 3
Misdiagnosis 2 2
Cardiac Arrest 2 2
Bruise/Contusion 2 2
Vertigo 2 2
Tachycardia 2 2
Stroke/CVA 2 2
Congestive Heart Failure 2 2
Muscle Weakness 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Bone Fracture(s) 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Aug-30-2022
2 Beckman Coulter Inc. II Oct-06-2021
3 Beckman Coulter, Inc. II Dec-20-2024
4 ORTHO-CLINICAL DIAGNOSTICS II Aug-08-2023
5 QUIDEL CARDIOVASCULAR INC I Jul-07-2023
6 Roche Diagnostics Operations, Inc. II May-14-2021
7 Siemens Healthcare Diagnostics, Inc. II Jul-06-2022
8 Siemens Healthcare Diagnostics, Inc. II Oct-02-2020
9 Siemens Healthcare Diagnostics, Inc. II Sep-02-2020
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