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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
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 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 25 25
Non Reproducible Results 24 24
High Test Results 15 15
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Output Problem 3 3
Unable to Obtain Readings 2 2
Incorrect Measurement 2 2
Mechanical Problem 1 1
Product Quality Problem 1 1
Calibration Problem 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
No Consequences Or Impact To Patient 5 5
Insufficient Information 1 1

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