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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device igg, antigen, antiserum, control
Product CodeDEW
Regulation Number 866.5510
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 4 4
2017 6 6
2018 1 1
2019 9 9
2020 19 19
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 30 30
Low Test Results 5 5
Incorrect Or Inadequate Test Results 4 4
High Test Results 1 1
Smoking 1 1
Device Reprocessing Problem 1 1
Complete Blockage 1 1
False Negative Result 1 1
Occlusion Within Device 1 1
Device Operates Differently Than Expected 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Pumping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 33 33
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Jul-19-2019
2 Beckman Coulter Inc. II Sep-30-2010
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