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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 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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