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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 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 173 173
High Test Results 123 124
Low Test Results 118 119
High Readings 94 94
Computer Software Problem 77 77
Low Readings 68 68
Output Problem 46 46
Non Reproducible Results 44 44
Incorrect Measurement 34 34
Insufficient Information 21 21
Erratic Results 19 19
No Device Output 15 15
Mechanical Problem 14 14
Patient Data Problem 13 13
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
Failure to Calibrate 4 4
Program or Algorithm Execution Failure 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
Failure to Prime 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 795 797
Insufficient Information 58 58
Cardiac Arrest 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Anemia 6 6
Respiratory Insufficiency 4 4
Needle Stick/Puncture 4 4
Vomiting 4 4
Abdominal Pain 3 3
Sepsis 3 3
Diabetic Ketoacidosis 3 3
Brain Injury 2 2
Abnormal Blood Gases 2 2
Respiratory Distress Syndrome of Newborns 2 2
Aneurysm 2 2
Convulsion/Seizure 2 2
Respiratory Acidosis 2 2
Hypoglycemia 2 2
Chest Pain 2 2
Exposure to Body Fluids 2 2
Fall 2 2
Hyperglycemia 2 2
Ventilator Dependent 1 1
Decreased Respiratory Rate 1 1
Respiratory Failure 1 1
Low Oxygen Saturation 1 1
Hemorrhage/Bleeding 1 1
Unspecified Vascular Problem 1 1
Hypoxia 1 1
Renal Failure 1 1
Heart Failure/Congestive Heart Failure 1 1
Eye Injury 1 1
Pneumonia 1 1
Congenital Defect/Deformity 1 1
Dehydration 1 1
Unspecified Kidney or Urinary Problem 1 1
Dyspnea 1 1
Renal Impairment 1 1
Pain 1 1
Diarrhea 1 1
Jaundice 1 1
Septic Shock 1 1
Cardiogenic Shock 1 1
Hepatitis 1 1
Osteomyelitis 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Electrolyte Imbalance 1 1
Atrial Fibrillation 1 1
Gastritis 1 1
Pericardial Effusion 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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