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TPLC
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Device
immunoassay method, troponin subunit
Regulation Description
Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product Code
MMI
Regulation Number
862.1215
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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