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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acid, lactic, enzymatic method
Product CodeKHP
Regulation Number 862.1450
Device Class 1


Premarket Reviews
ManufacturerDecision
ABAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT PONT OF CARE INC
  SUBSTANTIALLY EQUIVALENT 1
EPOCAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 19 19
2015 12 12
2016 41 41
2017 9 9
2018 12 12
2019 10 10
2020 6 6
2021 3 3
2022 7 7
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 39 39
Incorrect, Inadequate or Imprecise Result or Readings 34 34
High Test Results 34 34
Incorrect Or Inadequate Test Results 12 12
Calibration Problem 10 10
Device Displays Incorrect Message 5 5
High Readings 4 4
Low Readings 3 3
Insufficient Information 3 3
Improper or Incorrect Procedure or Method 3 3
False Negative Result 3 3
Non Reproducible Results 3 3
Display Difficult to Read 2 2
Device Operates Differently Than Expected 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
No Apparent Adverse Event 1 1
Patient Data Problem 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
No Display/Image 1 1
Product Quality Problem 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 54 54
No Consequences Or Impact To Patient 21 21
No Information 15 15
No Clinical Signs, Symptoms or Conditions 14 14
Misdiagnosis 8 8
Pneumonia 2 2
Renal Failure 2 2
No Code Available 2 2
Abdominal Pain 2 2
Adult Respiratory Distress Syndrome 1 1
Dehydration 1 1
Fall 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Hypoglycemia 1 1
Intraocular Pressure Increased 1 1
Overdose 1 1
Pain 1 1
Gastroesophageal Burn 1 1
Insufficient Information 1 1
Injury 1 1
Diabetic Ketoacidosis 1 1
Respiratory Failure 1 1
No Patient Involvement 1 1
Sepsis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Nov-09-2016
2 Abbott Point Of Care Inc. II Feb-18-2020
3 Beckman Coulter Inc. II Jun-08-2016
4 Beckman Coulter Inc. II Jan-28-2015
5 Beckman Coulter Inc. II Jun-27-2013
6 Beckman Coulter Inc. II May-24-2013
7 Horiba Instruments Inc II Feb-02-2016
8 Ortho-Clinical Diagnostics II Oct-17-2016
9 Radiometer America Inc II Sep-30-2013
10 Roche Diagnostics Corporation II Apr-13-2019
11 Siemens Healthcare Diagnostics Inc III Aug-19-2016
12 Siemens Healthcare Diagnostics Inc II Sep-24-2015
13 Siemens Healthcare Diagnostics Inc II Aug-28-2015
14 Siemens Healthcare Diagnostics Inc II Jul-18-2014
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