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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, natriuretic peptide
Product CodeNBC
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 7 7
2019 9 9
2020 6 6
2022 4 4
2023 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 29 29
High Test Results 10 10
Non Reproducible Results 7 7
Incorrect, Inadequate or Imprecise Result or Readings 3 3
False Negative Result 2 2
High Readings 2 2
Low Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 5 5
Congestive Heart Failure 2 2
Edema 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Oct-26-2020
2 ORTHO-CLINICAL DIAGNOSTICS II Jan-03-2019
3 Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc II Sep-17-2018
4 Siemens Healthcare Diagnostics, Inc. II Jun-01-2018
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