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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 149 149
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 193 193
Incorrect, Inadequate or Imprecise Result or Readings 180 180
Low Test Results 154 154
Non Reproducible Results 74 74
Output Problem 14 14
Incorrect Measurement 12 12
Low Readings 8 8
High Readings 5 5
Insufficient Information 4 4
No Apparent Adverse Event 3 3
Mechanical Problem 3 3
Unable to Obtain Readings 2 2
Smoking 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Calibration Problem 2 2
Chemical Problem 1 1
Nonstandard Device 1 1
Electrical /Electronic Property Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper Chemical Reaction 1 1
Failure to Calibrate 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 403 403
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
Chest Pain 3 3
Abdominal Pain 3 3
Muscle Weakness 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Fall 2 2
Heart Failure/Congestive Heart Failure 2 2
Gastrointestinal Hemorrhage 2 2
Cardiac Arrest 2 2
Nausea 2 2
Unspecified Respiratory Problem 2 2
Confusion/ Disorientation 2 2
Vomiting 2 2
Fatigue 2 2
Dizziness 2 2
Respiratory Distress 2 2
Diabetic Ketoacidosis 2 2
Low Blood Pressure/ Hypotension 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Heart Failure 1 1
Head Injury 1 1
Intracranial Hemorrhage 1 1
Anemia 1 1
Cellulitis 1 1
Unspecified Kidney or Urinary Problem 1 1
Respiratory Failure 1 1
Fever 1 1
Hyperglycemia 1 1
Tachycardia 1 1
Cataract 1 1
Rheumatoid Arthritis 1 1
Arthralgia 1 1
Test Result 1 1
Wheezing 1 1
Aneurysm 1 1
Liver Failure 1 1
Cough 1 1
Respiratory Acidosis 1 1
Insufficient Information 1 1
Biliary Cirrhosis 1 1
Renal Failure 1 1
Hematoma 1 1
Renal Disease, End Stage 1 1
Dehydration 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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