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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion specific, sodium
Regulation Description Sodium test system.
Product CodeJGS
Regulation Number 862.1665
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 89 89
2021 91 91
2022 60 60
2023 109 109
2024 148 148
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 191 191
Incorrect, Inadequate or Imprecise Result or Readings 180 180
Low Test Results 163 163
Non Reproducible Results 81 81
Output Problem 13 13
Incorrect Measurement 12 12
Low Readings 7 7
Insufficient Information 5 5
High Readings 5 5
Mechanical Problem 3 3
No Apparent Adverse Event 3 3
Smoking 2 2
Unable to Obtain Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Calibration Problem 2 2
Chemical Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Use of Device Problem 1 1
Infusion or Flow Problem 1 1
Failure to Calibrate 1 1
Nonstandard Device 1 1
Improper Chemical Reaction 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 410 410
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 21 21
No Information 11 11
High Blood Pressure/ Hypertension 4 4
Unspecified Heart Problem 4 4
Abdominal Pain 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Chest Pain 3 3
Muscle Weakness 3 3
Unspecified Respiratory Problem 2 2
Heart Failure/Congestive Heart Failure 2 2
Fall 2 2
Vomiting 2 2
Confusion/ Disorientation 2 2
Cardiac Arrest 2 2
Diabetic Ketoacidosis 2 2
Dizziness 2 2
Gastrointestinal Hemorrhage 2 2
Respiratory Distress 2 2
Nausea 2 2
Fatigue 2 2
Head Injury 1 1
Hematoma 1 1
Test Result 1 1
Heart Failure 1 1
Anemia 1 1
Cellulitis 1 1
Respiratory Acidosis 1 1
Cataract 1 1
Fever 1 1
Intracranial Hemorrhage 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Wheezing 1 1
Insufficient Information 1 1
Dehydration 1 1
Hyperglycemia 1 1
Renal Disease, End Stage 1 1
Unspecified Kidney or Urinary Problem 1 1
Biliary Cirrhosis 1 1
Renal Failure 1 1
Tachycardia 1 1
Cough 1 1
Aneurysm 1 1
Arthralgia 1 1
Rheumatoid Arthritis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Liver Failure 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Feb-18-2020
2 Mindray DS USA, Inc. dba Mindray North America II Jan-30-2020
3 Nova Biomedical Corporation II Nov-01-2023
4 Siemens Healthcare Diagnostics Inc II Dec-01-2023
5 Siemens Healthcare Diagnostics, Inc. II Jan-03-2022
6 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
7 Siemens Healthcare Diagnostics, Inc. II Jul-06-2021
8 Siemens Healthcare Diagnostics, Inc. II Jun-16-2021
9 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
10 Siemens Healthcare Diagnostics, Inc. II Apr-24-2020
11 Siemens Healthcare Diagnostics, Inc. II Mar-02-2020
12 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
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