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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion-specific, chloride
Regulation Description Chloride test system.
Product CodeCGZ
Regulation Number 862.1170
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2022 5 5
2023 10 10
2024 11 11
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 11 11
Non Reproducible Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Low Test Results 9 9
Output Problem 3 3
Mechanical Problem 1 1
Material Integrity Problem 1 1
Degraded 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Consequences Or Impact To Patient 3 3

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