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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
Product CodeDOP
Regulation Number 862.2860
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 2 2
Incorrect Or Inadequate Test Results 1 1
Device Operates Differently Than Expected 1 1
Output Problem 1 1
Missing Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AB SCIEX II Oct-26-2021
2 Agilent Technologies, Inc. II Aug-23-2019
3 PerkinElmer Health Sciences Canada, Inc. II Nov-28-2018
4 Thermo Fisher Scientific II Mar-10-2021
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