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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode measurement, blood-gases (pco2, po2) and blood ph
Regulation Description Blood gases (PCO2, PO2) and blood pH test system.
Product CodeCHL
Regulation Number 862.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY CO
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OPTI MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER MEDICALS APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 147 147
2022 138 138
2023 177 179
2024 196 196
2025 212 212
2026 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 177 177
Low Test Results 142 143
High Test Results 129 130
High Readings 104 104
Computer Software Problem 80 80
Low Readings 79 79
Output Problem 47 47
Non Reproducible Results 44 44
Incorrect Measurement 38 38
Insufficient Device Problem Information 21 21
Patient Data Problem 20 20
Imprecise or Erratic Results 20 20
Mechanical Problem 16 16
No Device Output 15 15
Calibration Problem 11 11
No Apparent Adverse Event 9 9
Smoking 8 8
Unable to Obtain Readings 8 8
Infusion or Flow Problem 8 8
Missing Test Results 8 8
Device Displays Incorrect Message 7 7
False Negative Result 6 6
Failure to Calibrate 6 6
Use of Device Problem 6 6
Electrical /Electronic Property Problem 5 5
Program or Algorithm Execution Failure 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Fluid/Blood Leak 3 3
Improper or Incorrect Procedure or Method 3 3
Application Program Freezes or Fails to Launch 3 3
Date/Time-Related Software Problem 3 3
Data Problem 3 3
Loss of Data 2 2
False Positive Result 2 2
Product Quality Problem 2 2
Optical Problem 2 2
Difficult to Remove 2 2
Material Integrity Problem 2 2
Failure to Obtain Sample 2 2
Activation, Positioning or Separation Problem 2 2
Sparking 2 2
Material Deformation 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unintended Ejection 1 1
Material Discolored 1 1
Ejection Problem 1 1
Failure to Prime 1 1
Retraction Problem 1 1
Installation-Related Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 870 872
Insufficient Information 65 65
Cardiac Arrest 7 7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 6 6
Anemia 6 6
Needle Stick/Puncture 6 6
Respiratory Insufficiency 4 4
Vomiting 4 4
Abdominal Pain 3 3
Sepsis 3 3
Elevated ketones/Diabetic Ketoacidosis 3 3
Exposure to Body Fluids 3 3
Hyperglycemia 2 2
Fall 2 2
Brain Injury 2 2
Abnormal Blood Gases 2 2
Hypoglycemia 2 2
Respiratory Distress Syndrome of Newborns 2 2
Convulsion/Seizure 2 2
Aneurysm 2 2
Respiratory Acidosis 2 2
Chest Pain 2 2
Hyperkalemia 2 2
Hemorrhage/Blood Loss/Bleeding 1 1
Pain 1 1
Renal Impairment 1 1
Unspecified Kidney or Urinary Problem 1 1
Congenital Defect/Deformity 1 1
Eye Injury 1 1
Pneumonia 1 1
Heart Failure/Congestive Heart Failure 1 1
Renal Failure 1 1
Hypoxia 1 1
Unspecified Vascular Problem 1 1
Ventilator Dependent 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Aortic dissection 1 1
Altered State of Consciousness 1 1
Decreased Level of Consciousness 1 1
Dyspnea 1 1
Dehydration 1 1
Cardiogenic Shock 1 1
Jaundice 1 1
Septic Shock 1 1
Diarrhea 1 1
Osteomyelitis 1 1
Hepatitis 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Apr-29-2026
2 Abbott Point Of Care Inc. II Sep-17-2025
3 Abbott Point Of Care Inc. II Sep-17-2025
4 Abbott Point Of Care Inc. II Jan-19-2021
5 Instrumentation Laboratory II Aug-06-2026
6 Instrumentation Laboratory II Jul-29-2026
7 Instrumentation Laboratory II Mar-10-2026
8 Instrumentation Laboratory II Nov-21-2023
9 Radiometer Medical ApS II Apr-23-2025
10 Radiometer Medical ApS II Jul-24-2024
11 Radiometer Medical ApS II Jul-01-2022
12 Radiometer Medical ApS II Jun-15-2021
13 Siemens Healthcare Diagnostics Inc II Apr-29-2026
14 Siemens Healthcare Diagnostics Inc II Jul-31-2025
15 Siemens Healthcare Diagnostics Inc II Apr-29-2025
16 Siemens Healthcare Diagnostics Inc II Nov-01-2024
17 Siemens Healthcare Diagnostics Inc II Jun-26-2024
18 Siemens Healthcare Diagnostics Inc II Dec-21-2023
19 Siemens Healthcare Diagnostics Inc II Aug-28-2023
20 Siemens Healthcare Diagnostics Inc II Mar-03-2023
21 Siemens Healthcare Diagnostics Inc II Jul-12-2022
22 Siemens Healthcare Diagnostics, Inc. II Dec-20-2024
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