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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion based, enzymatic, creatinine
Regulation Description Creatinine test system.
Product CodeCGL
Regulation Number 862.1225
Device Class 2

MDR Year MDR Reports MDR Events
2021 20 20
2022 11 12
2023 5 5
2024 7 7
2025 8 8
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 30 30
Low Test Results 9 10
Non Reproducible Results 6 6
Erratic Results 3 3
Incorrect Measurement 3 3
High Test Results 2 2
Low Readings 2 2
Insufficient Information 1 1
Smoking 1 1
Defective Component 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Insufficient Information 7 8
Abdominal Pain 2 2
High Blood Pressure/ Hypertension 1 1
Sepsis 1 1
Abnormal Blood Gases 1 1
Pain 1 1
Renal Impairment 1 1
Cardiomyopathy 1 1
Cancer 1 1
Ischemia Stroke 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
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