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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device counter, cell, automated (particle counter)
Product CodeGKL
Regulation Number 864.5200
Device Class 2

MDR Year MDR Reports MDR Events
2020 13 13
2021 11 11
2022 7 7
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 21 21
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Leak/Splash 3 3
Illegible Information 2 2
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 5 5
No Patient Involvement 4 4
Chemical Exposure 1 1
No Known Impact Or Consequence To Patient 1 1

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