Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 91 91
2022 60 64
2023 98 102
2024 96 98
2025 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 168 170
Low Test Results 144 151
Incorrect, Inadequate or Imprecise Result or Readings 122 124
Non Reproducible Results 73 76
Output Problem 7 7
Insufficient Information 7 7
Incorrect Measurement 6 6
Smoking 2 2
High Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Calibration Problem 2 2
Low Readings 2 2
No Apparent Adverse Event 2 2
Failure to Calibrate 2 2
Device Ingredient or Reagent Problem 1 1
Mechanical Problem 1 1
Unable to Obtain Readings 1 2
Use of Device Problem 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 383 393
High Blood Pressure/ Hypertension 4 4
Unspecified Heart Problem 4 4
Abdominal Pain 3 3
No Consequences Or Impact To Patient 3 3
Muscle Weakness 3 3
Unspecified Respiratory Problem 2 2
Gastrointestinal Hemorrhage 2 2
Diabetic Ketoacidosis 2 2
Cardiac Arrest 2 2
Heart Failure/Congestive Heart Failure 2 2
Pain 2 2
Respiratory Failure 1 1
Low Blood Pressure/ Hypotension 1 1
Hemorrhage/Bleeding 1 1
Aneurysm 1 1
Cough 1 1
Tachycardia 1 1
Renal Failure 1 1
Biliary Cirrhosis 1 1
Unspecified Kidney or Urinary Problem 1 1
Fall 1 1
Dehydration 1 1
Insufficient Information 1 1
Vomiting 1 1
Chest Pain 1 1
Intracranial Hemorrhage 1 1
Fever 1 1
Confusion/ Disorientation 1 1
Respiratory Acidosis 1 1
Cellulitis 1 1
Anemia 1 1
Hematoma 1 1
Head Injury 1 1
Dizziness 1 1
Wheezing 1 1
Nausea 1 1
Fatigue 1 1
Arthralgia 1 1
Rheumatoid Arthritis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Liver Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nova Biomedical Corporation II Nov-01-2023
2 Siemens Healthcare Diagnostics Inc II Aug-05-2025
3 Siemens Healthcare Diagnostics Inc II Dec-01-2023
4 Siemens Healthcare Diagnostics, Inc. II Jan-03-2022
5 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
6 Siemens Healthcare Diagnostics, Inc. II Jul-06-2021
7 Siemens Healthcare Diagnostics, Inc. II Jun-16-2021
8 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
-
-