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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bilirubin (total and unbound) in the neonate test system
Regulation Description Bilirubin (total and unbound) in the neonate test system.
Product CodeMQM
Regulation Number 862.1113
Device Class 1


Premarket Reviews
ManufacturerDecision
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical Problem 14
Low Test Results 11
Adverse Event Without Identified Device or Use Problem 8
High Test Results 6
Low Readings 3
Incorrect Or Inadequate Test Results 2
Probe 2
Calibration Problem 2
Patient Data Problem 1
Pump 1
Insufficient Information 1
High Readings 1
Total Device Problems 52

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. I Jun-07-2018
2 Siemens Healthcare Diagnostics Inc II Mar-06-2015

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