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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigen, inflammatory response marker, sepsis
Definition An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
Product CodeNTM
Regulation Number 866.3210
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2019 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2 2
Non Reproducible Results 2 2
Low Test Results 1 1
False Negative Result 1 1
False Positive Result 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Siemens Healthcare Diagnostics, Inc II May-23-2014
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