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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 1

MDR Year MDR Reports MDR Events
2021 147 147
2022 138 138
2023 177 179
2024 196 196
2025 212 212
2026 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 170 170
High Test Results 120 121
Low Test Results 115 116
High Readings 91 91
Low Readings 67 67
Computer Software Problem 65 65
Output Problem 44 44
Non Reproducible Results 44 44
Incorrect Measurement 34 34
Insufficient Information 21 21
Erratic Results 18 18
No Device Output 15 15
Patient Data Problem 13 13
Mechanical Problem 12 12
Calibration Problem 10 10
No Apparent Adverse Event 9 9
Device Displays Incorrect Message 7 7
Smoking 7 7
Unable to Obtain Readings 7 7
False Negative Result 6 6
Use of Device Problem 6 6
Infusion or Flow Problem 6 6
Electrical /Electronic Property Problem 5 5
Missing Test Results 5 5
Program or Algorithm Execution Failure 4 4
Failure to Calibrate 4 4
Fluid/Blood Leak 3 3
Improper or Incorrect Procedure or Method 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Product Quality Problem 3 3
Data Problem 3 3
Date/Time-Related Software Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Optical Problem 2 2
Material Integrity Problem 2 2
Failure to Obtain Sample 2 2
False Positive Result 2 2
Loss of Data 2 2
Leak/Splash 2 2
Device Difficult to Setup or Prepare 1 1
Unintended Ejection 1 1
Material Discolored 1 1
Ejection Problem 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Deformation 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 766 768
Insufficient Information 57 57
Cardiac Arrest 7 7
Anemia 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Respiratory Insufficiency 4 4
Needle Stick/Puncture 4 4
Vomiting 4 4
Sepsis 3 3
Abdominal Pain 3 3
Diabetic Ketoacidosis 3 3
Respiratory Acidosis 2 2
Convulsion/Seizure 2 2
Abnormal Blood Gases 2 2
Aneurysm 2 2
Fall 2 2
Chest Pain 2 2
Exposure to Body Fluids 2 2
Respiratory Distress Syndrome of Newborns 2 2
Brain Injury 2 2
Hyperglycemia 2 2
Hypoglycemia 2 2
Hypoxia 1 1
Unspecified Infection 1 1
Muscle Weakness 1 1
Nausea 1 1
Pain 1 1
Pneumonia 1 1
Renal Failure 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Cardiogenic Shock 1 1
Jaundice 1 1
Electrolyte Imbalance 1 1
Septic Shock 1 1
Congenital Defect/Deformity 1 1
Dehydration 1 1
Diarrhea 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Eye Injury 1 1
Gastritis 1 1
Hemorrhage/Bleeding 1 1
Hepatitis 1 1
Hyperbilirubinemia 1 1
Atrial Fibrillation 1 1
Unspecified Vascular Problem 1 1
Heart Failure/Congestive Heart Failure 1 1
Pancreatitis 1 1
Rectal Anastomotic Leakage 1 1
Hyponatremia 1 1

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