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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


Premarket Reviews
ManufacturerDecision
BIOSYSTEMS S.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 7 7
2022 4 4
2023 31 31
2024 38 38
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 38 38
Low Test Results 37 37
High Test Results 25 25
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Output Problem 4 4
Incorrect Measurement 3 3
Unable to Obtain Readings 2 2
Optical Problem 2 2
Chemical Problem 1 1
Mechanical Problem 1 1
High Readings 1 1
Calibration Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86 86
No Consequences Or Impact To Patient 5 5
Insufficient Information 1 1

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