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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 48 48
Non Reproducible Results 18 18
High Test Results 15 15
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Low Readings 3 3
Insufficient Information 2 2
High Readings 2 2
False Negative Result 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Failure to Calibrate 1 1
False Positive Result 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
No Consequences Or Impact To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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