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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device to detect and measure procalcitonin (pct) in human clinical specimens
Definition An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.
Product CodePMT
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
B.R.A.H.M.S GMBH
  GRANTED 1
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 3 3
2019 1 1
2020 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4 4
Incorrect Or Inadequate Test Results 3 3
Low Test Results 2 2
Non Reproducible Results 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corporation II Apr-04-2018
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