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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
2022 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 2 2
Flare or Flash 1 1
Compatibility Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Missing Test Results 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AB SCIEX II Oct-26-2021
2 AB Sciex, LLC II Oct-05-2023
3 Agilent Technologies, Inc. II Aug-23-2019
4 Thermo Fisher Scientific II Mar-10-2021
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