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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mass spectrometer, clinical use
Regulation Description Mass spectrometer for clinical use.
Product CodeDOP
Regulation Number 862.2860
Device Class 1

Device Problems
Computer Software Problem 2
Incorrect Or Inadequate Test Results 1
Device Operates Differently Than Expected 1
Total Device Problems 4

Recalls
Manufacturer Recall Class Date Posted
1 Ab Sciex II Aug-12-2016
2 Ab Sciex II May-15-2016
3 Ab Sciex II Apr-29-2016
4 Agilent Technologies, Inc. II Aug-23-2019
5 PerkinElmer Health Sciences Canada, Inc. II Nov-28-2018
6 Thermo Finnigan LLC II Sep-09-2016

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