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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device procalcitonin assay
Definition To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
Product CodePRI
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
B.R.A.H.M.S GMBH
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 1 1
2019 4 4
2020 3 3
2021 155 155
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 144 144
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
High Test Results 6 6
Low Test Results 6 6
False Negative Result 2 2
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 161 161
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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