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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
Regulation Description B-type natriuretic peptide test system.
Product CodeNBC
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
AXIS-SHIELD DIAGNOSTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2022 4 4
2023 26 26
2024 18 18
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 39 39
Non Reproducible Results 17 17
High Test Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Low Readings 2 2
Insufficient Information 2 2
False Positive Result 1 1
High Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Calibrate 1 1
False Negative Result 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 49
No Consequences Or Impact To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Oct-26-2020
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