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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 98 98
2024 96 96
2025 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 182 182
Incorrect, Inadequate or Imprecise Result or Readings 163 163
Low Test Results 152 152
Non Reproducible Results 76 76
Output Problem 11 11
Insufficient Information 6 6
Low Readings 6 6
High Readings 5 5
Incorrect Measurement 4 4
Smoking 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Calibration Problem 2 2
No Apparent Adverse Event 2 2
Failure to Calibrate 2 2
Mechanical Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unable to Obtain Readings 1 1
Use of Device Problem 1 1
Nonstandard Device 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 388 388
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 Aug-05-2025
5 Siemens Healthcare Diagnostics Inc II Dec-01-2023
6 Siemens Healthcare Diagnostics, Inc. II Jan-03-2022
7 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
8 Siemens Healthcare Diagnostics, Inc. II Jul-06-2021
9 Siemens Healthcare Diagnostics, Inc. II Jun-16-2021
10 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
11 Siemens Healthcare Diagnostics, Inc. II Apr-24-2020
12 Siemens Healthcare Diagnostics, Inc. II Mar-02-2020
13 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
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