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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device titrimetric with edta and indicator, calcium
Regulation Description Calcium test system.
Product CodeCHW
Regulation Number 862.1145
Device Class 2

MDR Year MDR Reports MDR Events
2021 7 7
2022 4 4
2023 22 23
2024 23 25
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 33 34
Low Test Results 28 31
Incorrect, Inadequate or Imprecise Result or Readings 21 22
High Test Results 21 21
Output Problem 4 4
Unable to Obtain Readings 2 2
Optical Problem 2 2
Mechanical Problem 1 2
High Readings 1 1
Calibration Problem 1 1
Product Quality Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83 86
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1

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