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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 1
ABBOTT POINT OF CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
OPTI MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER MEDICALS APS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 147 147
2022 138 138
2023 177 177
2024 196 196
2025 195 195

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 201 201
High Test Results 122 122
Low Test Results 114 114
High Readings 98 98
Non Reproducible Results 77 77
Low Readings 72 72
Computer Software Problem 65 65
Output Problem 41 41
Incorrect Measurement 40 40
Insufficient Information 26 26
Erratic Results 17 17
No Device Output 15 15
Patient Data Problem 15 15
Mechanical Problem 12 12
Use of Device Problem 9 9
No Apparent Adverse Event 9 9
Calibration Problem 8 8
Smoking 7 7
Device Displays Incorrect Message 7 7
Unable to Obtain Readings 7 7
False Negative Result 7 7
Infusion or Flow Problem 6 6
Electrical /Electronic Property Problem 5 5
Missing Test Results 5 5
Fluid/Blood Leak 4 4
Program or Algorithm Execution Failure 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Calibrate 4 4
Leak/Splash 3 3
Improper or Incorrect Procedure or Method 3 3
Overheating of Device 3 3
Date/Time-Related Software Problem 3 3
Data Problem 3 3
Product Quality Problem 3 3
Loss of Data 2 2
Failure to Obtain Sample 2 2
Material Integrity Problem 2 2
False Positive Result 2 2
Optical Problem 2 2
Coagulation in Device or Device Ingredient 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Device Contaminated at the User Facility 1 1
Display or Visual Feedback Problem 1 1
Corroded 1 1
Difficult to Open or Close 1 1
Human-Device Interface Problem 1 1
Suction Problem 1 1
Nonstandard Device 1 1
Melted 1 1
Grounding Malfunction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 766 766
Insufficient Information 57 57
No Known Impact Or Consequence To Patient 31 31
No Consequences Or Impact To Patient 28 28
No Information 15 15
Anemia 10 10
Cardiac Arrest 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Vomiting 5 5
Needle Stick/Puncture 5 5
Abdominal Pain 4 4
Respiratory Insufficiency 4 4
Fall 3 3
No Patient Involvement 3 3
Sepsis 3 3
Chest Pain 3 3
Diabetic Ketoacidosis 3 3
Hyperglycemia 2 2
Renal Impairment 2 2
Septic Shock 2 2
Exposure to Body Fluids 2 2
Pregnancy 2 2
Hypoglycemia 2 2
Respiratory Acidosis 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Convulsion/Seizure 2 2
Respiratory Distress Syndrome of Newborns 2 2
Abnormal Blood Gases 2 2
No Code Available 2 2
Brain Injury 2 2
Respiratory Distress 2 2
Hyperbilirubinemia 2 2
Limb Fracture 1 1
Heart Failure/Congestive Heart Failure 1 1
Pneumonia 1 1
Eye Injury 1 1
Biliary Cirrhosis 1 1
Renal Failure 1 1
Aneurysm 1 1
Congenital Defect/Deformity 1 1
Hypoxia 1 1
Unspecified Kidney or Urinary Problem 1 1
Pain 1 1
Hemorrhage/Bleeding 1 1
Unspecified Vascular Problem 1 1
Dyspnea 1 1
Dehydration 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 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 Abbott Point Of Care Inc. II Feb-18-2020
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 Radiometer Medical ApS II Jul-04-2020
11 Radiometer Medical ApS II Jun-29-2020
12 Radiometer Medical ApS II May-28-2020
13 Radiometer Medical ApS II May-01-2020
14 Radiometer Medical ApS II Apr-22-2020
15 Radiometer Medical ApS II Apr-08-2020
16 Siemens Healthcare Diagnostics Inc II Jul-31-2025
17 Siemens Healthcare Diagnostics Inc II Apr-29-2025
18 Siemens Healthcare Diagnostics Inc II Nov-01-2024
19 Siemens Healthcare Diagnostics Inc II Jun-26-2024
20 Siemens Healthcare Diagnostics Inc II Dec-21-2023
21 Siemens Healthcare Diagnostics Inc II Aug-28-2023
22 Siemens Healthcare Diagnostics Inc II Mar-03-2023
23 Siemens Healthcare Diagnostics Inc II Jul-12-2022
24 Siemens Healthcare Diagnostics Inc II Jun-26-2020
25 Siemens Healthcare Diagnostics, Inc. II Dec-20-2024
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